Arborpharma.com

?6$!"(-$2#.()*%(&/$(-$%&$8#$0-#.$*-$.(,#)%#.$83$%"#$'"3-()(*/6$C%$(-$1&,$#A%#,/*+$0-#$$$ $$$$&/+36$KT&(.$)&/%*)%$Q(%"$%"#$#3#-6 =6$I*%(#/%-$-"&0+.$8#$*.T(-#.$/&%$%&$0-#$%"(-$2#.()*%(&/$1&,$*/3$.(-&,.#,$&%"#,$ $$$$%"*/$1&,$Q"()"$(%$Q*-$',#-),(8#.6 ;6$!"#$%,#*%#.$-S(/$*,#*$-"&0+.$/&%$8#$8*/.*5#.$&,$&%"#,Q(-#$)&T#,#.$&,$ !"#$%&'(&)*+
$$$$Q,*''#.$*-$%&$8#$&))+0-(T#$0/+#--$.(,#)%#.$83$%"#$'"3-()(*/ Information for the Patient
:6$I*%(#/%-$-"&0+.$,#'&,%$*/3$-(5/-$&1$+&)*+$*.T#,-#$,#*)%(&/-$#-'#)(*++3$0/.#,$ Patients using topical corticosteroids should receive the following information and instructions: !"#$%&'()*+$)&,%()&-%#,&(.-$)&/-%(%0%#$*$)+*--$&1$',(2*,(+3$-3/%"#%()$-%#,&(.-$0-#.$ *-$*/%(4(/1+*22*%&,3$*/.$*/%(',0,(%()$*5#/%-6$73.,&)&,%(-&/#$(-$*$2#28#,$&1$%"(-$ ]6$I*,#/%-$&1$'#.(*%,()$'*%(#/%-$-"&0+.$8#$*.T(-#.$/&%$%&$0-#$%(5"%41(%%(/5$.(*'#,-$ 1. This medication is to be used as directed by the physician. It is for external use only. Avoid )+*--6$9"#2()*++3$"3.,&)&,%(-&/#$(-$',#5/4:4#/#4;<$=>4.(&/#<$??<$?@<$=?$ $$$$&,$'+*-%()$'*/%-$&/$*$)"(+.$8#(/5$%,#*%#.$(/$%"#$.(*'#,$*,#*<$*-$%"#-#$5*,2#/%-$ 4%,("3.,&A3<$BCC$DE46$C%-$-%,0)%0,*+$1&,20+*$(-F 2. Patients should be advised not to use this medication for any disorder other than for which it $$$$2*3$)&/-%(%0%#$&))+0-(T#$.,#--(/5-6$ 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be DESCRIPTION
occlusive unless directed by the physician.
!"#$1&++&Q(/5$%#-%-$2*3$8#$"#+'10+$(/$#T*+0*%(/5$%"#$7IK$*A(-$-0'',#--(&/F$ The topical corticosteroids constitute a class of primarily synthetic steroids used as 4. Patients should report any signs of local adverse reactions especially under occlusive $$$$$$^$$N,(/*,3$1,##$)&,%(-&+$%#-% antiinflammatory and antipruritic agents. The steroids in this class include Triamcinolone Acetonide. Triamcinolone Acetonide is designated chemically as 9-Fluoro-11β,16α,17,21- 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. With the on a child being treated in the diaper area, as these garments may constitute occlusive 7#$&)*'8+*+-)-9.:;,#8+*+-)-9.#*<.)%=#)$%+*,.'2.>+$,)0),5 molecular formula of C24H31FO6 and a molecular weight of 434.51. The structural formula H&/54%#,2$*/(2*+$-%0.(#-$"*T#$/&%$8##/$'#,1&,2#.$%&$#T*+0*%#$%"#$)*,)(/&5#/()$ Laboratory Tests
G*)"$2H$&1$IGJCKJGLM479$B73.,&)&,%(-&/#$H&%(&/$NOI$=PE$)&/%*(/-$=>$25$ '&%#/%(*+$&,$%"#$#11#)%$&/$1#,%(+(%3$&1$%&'()*+$)&,%()&-%#,&(.-6$ A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis "3.,&)&,%(-&/#$NOI$(/$*$+&%(&/$8*-#$)&/-(-%(/5$&1$Q*%#,<$(-&',&'3+$*+)&"&+<$ '&+3-&,8*%#$=><$',&'3+#/#$5+3)&+<$*/.$8#/R*+S&/(02$)"+&,(.#6$ O%0.(#-$%&$.#%#,2(/#$20%*5#/()(%3$Q(%"$',#./(-&+&/#$*/.$"3.,&)&,%(-&/#$"*T#$ Carcinogenesis, Mutagenesis, and Impairment of Fertility
$,&*&$-,.'/-%0-$),)12+.
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and !&'()*+$)&,%()&-%#,&(.-$-"*,#$*/%(4(/1+*22*%&,3<$*/%(',0,(%()$*/.$T*-&)&/-%,()%(T#$ 9&,%()&-%#,&(.-$*,#$5#/#,*++3$%#,*%&5#/()$(/$+*8&,*%&,3$*/(2*+-$Q"#/$ hydrocortisone have revealed negative results.
*.2(/(-%#,#.$-3-%#2()*++3$*%$,#+*%(T#+3$+&Q$.&-*5#$+#T#+-6$!"#$2&,#$'&%#/%$ Pregnancy. Teratogenic Effects, Pregnancy Category C
!"#$2#)"*/(-2$&1$*/%(4(/1+*22*%&,3$*)%(T(%3$&1$%"#$%&'()*+$)&,%()&-%#,&(.-$(-$ )&,%()&-%#,&(.-$"*T#$8##/$-"&Q/$%&$8#$%#,*%&5#/()$*1%#,$.#,2*+$*''+()*%(&/$(/$ Corticosteroids are generally teratogenic in laboratory animals when administered systemically at 0/)+#*,6$U*,(&0-$+*8&,*%&,3$2#%"&.-<$(/)+0.(/5$T*-&)&/-%,()%&,$*--*3-<$*,#$0-#.$ +*8&,*%&,3$*/(2*+-6$!"#,#$*,#$/&$*.#\0*%#$*/.$Q#++4)&/%,&++#.$-%0.(#-$(/$ Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg Triamcinolone relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after %&$)&2'*,#$*/.$',#.()%$'&%#/)(#-$*/.V&,$)+(/()*+$#11()*)(#-$&1$%"#$%&'()*+$ ',#5/*/%$Q&2#/$&/$%#,*%&5#/()$#11#)%-$1,&2$%&'()*++3$*''+(#.$)&,%()&-%#,&(.-6$ Acetonide in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters dermal application in laboratory animals. There are no adequate and well-controlled studies in )&,%()&-%#,&(.-6$!"#,#$(-$-&2#$#T(.#/)#$%&$-055#-%$%"*%$*$,#)&5/(R*8+#$ !"#,#1&,#<$%&'()*+$)&,%()&-%#,&(.-$-"&0+.$8#$0-#.$.0,(/5$',#5/*/)3$&/+3$(1$%"#$ wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical '&%#/%(*+$8#/#_%$X0-%(_#-$%"#$'&%#/%(*+$,(-S$%&$%"#$1#%0-6$J,05-$&1$%"(-$)+*--$-"&0+.$ corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk )&,,#+*%(&/$#A(-%-$8#%Q##/$T*-&)&/-%,()%&,$'&%#/)3$*/.$%"#,*'#0%()$#11()*)3$(/$ to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, /&%$8#$0-#.$#A%#/-(T#+3$&/$',#5/*/%$'*%(#/%-<$(/$+*,5#$*2&0/%-<$&,$1&,$',&+&/5#.$ CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
Nursing Mothers
!"#$#A%#/%$&1$'#,)0%*/#&0-$*8-&,'%(&/$&1$%&'()*+$)&,%()&-%#,&(.-$(-$.#%#,2(/#.$83$ ?;$-)*8.:',"+$- The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various It is not known whether topical administration of corticosteroids could result in sufficient systemic C%$(-$/&%$S/&Q/$Q"#%"#,$%&'()*+$*.2(/(-%,*%(&/$&1$)&,%()&-%#,&(.-$)&0+.$,#-0+%$(/$ laboratory methods, including vasoconstrictor assays, are used to compare and predict absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids 2*/3$1*)%&,-$(/)+0.(/5$%"#$T#"()+#<$%"#$(/%#5,(%3$&1$%"#$#'(.#,2*+$8*,,(#,<$*/.$%"#$ -011()(#/%$-3-%#2()$*8-&,'%(&/$%&$',&.0)#$.#%#)%*8+#$\0*/%(%(#-$(/$8,#*-%$2(+S6$ potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. 0-#$&1$&))+0-(T#$.,#--(/5-6$!&'()*+$)&,%()&-%#,&(.-$)*/$8#$*8-&,8#.$1,&2$/&,2*+$ O3-%#2()*++3$*.2(/(-%#,#.$)&,%()&-%#,&(.-$*,#$-#),#%#.$(/%&$8,#*-%$2(+S$(/$ suggest that a recognizable correlation exists between vasoconstrictor potency and Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing (/%*)%$-S(/6$C/1+*22*%(&/$*/.V&,$&%"#,$.(-#*-#$',&)#--#-$(/$%"#$-S(/$(/),#*-#$ \0*/%(%(#-$/&%$+(S#+3$%&$"*T#$*$.#+#%#,(&0-$#11#)%$&/$%"#$(/1*/%6$ '#,)0%*/#&0-$*8-&,'%(&/6$W))+0-(T#$.,#--(/5-$-08-%*/%(*++3$(/),#*-#$%"#$ '#,)0%*/#&0-$*8-&,'%(&/$&1$%&'()*+$)&,%()&-%#,&(.-6$!"0-<$&))+0-(T#$.,#--(/5-$ Z#T#,%"#+#--<$)*0%(&/$-"&0+.$8#$#A#,)(-#.$Q"#/$%&'()*+$)&,%()&-%#,&(.-$*,#$ Pharmacokinetics
Pediatric Use
*.2(/(-%#,#.$%&$*$/0,-(/5$Q&2*/6$ The extent of percutaneous absorption of topical corticosteroids is determined by many Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis 2*3$8#$*$T*+0*8+#$%"#,*'#0%()$*.X0/)%$1&,$%,#*%2#/%$&1$,#-(-%*/%$.#,2*%&-#-6$ factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial W/)#$*8-&,8#.$%",&05"$%"#$-S(/<$%&'()*+$)&,%()&-%#,&(.-$*,#$"*/.+#.$%",&05"$ I#.(*%,()$'*%(#/%-$2*3$.#2&/-%,*%#$5,#*%#,$-0-)#'%(8(+(%3$%&$%&'()*+$ Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other hypertension have been reported in pediatric patients receiving topical corticosteroids.
'"*,2*)&S(/#%()$'*%"Q*3-$-(2(+*,$%&$-3-%#2()*++3$*.2(/(-%#,#.$)&,%()&-%#,&(.-6$ )&,%()&-%#,&(.4(/.0)#.$7IK$*A(-$-0'',#--(&/$*/.$90-"(/5[-$-3/.,&2#$%"*/$ disease processes in the skin increase percutaneous absorption. Occlusive dressings 9&,%()&-%#,&(.-$*,#$8&0/.$%&$'+*-2*$',&%#(/-$(/$T*,3(/5$.#5,##-6$9&,%()&-%#,&(.-$ 2*%0,#$'*%(#/%-$8#)*0-#$&1$*$+*,5#,$-S(/$-0,1*)#$*,#*$%&$8&.3$Q#(5"%$,*%(&6$ substantially increase the percutaneous absorption of topical corticosteroids. Thus, Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations *,#$2#%*8&+(R#.$',(2*,(+3$(/$%"#$+(T#,$*/.$*,#$%"#/$#A),#%#.$83$%"#$S(./#3-6$O&2#$ 73'&%"*+*2()4'(%0(%*,34*.,#/*C$B7IKE$*A(-$-0'',#--(&/<$90-"(/5[-$-3/.,&2#<$ dermatoses (See DOSAGE AND ADMINISTRATION section).
of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
&1$%"#$%&'()*+$)&,%()&-%#,&(.-$*/.$%"#(,$2#%*8&+(%#-$*,#$*+-&$#A),#%#.$(/%&$%"#$8(+#6$ */.$(/%,*),*/(*+$"3'#,%#/-(&/$"*T#$8##/$,#'&,%#.$(/$)"(+.,#/$,#)#(T(/5$%&'()*+$ Once absorbed through the skin, topical corticosteroids are handled through pharmacoki- Administration of topical corticosteroids to pediatric patients should be limited to the least amount &*!&$-(&)*#.-*!.3#-1"+$
)&,%()&-%#,&(.-6$M*/(1#-%*%(&/-$&1$*.,#/*+$-0'',#--(&/$(/$)"(+.,#/$(/)+0.#$+(/#*,$ netic pathways similar to systemically administered corticosteroids. Corticosteroids are compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with 73.,&)&,%(-&/#$H&%(&/$(-$(/.()*%#.$1&,$%"#$,#+(#1$&1$%"#$(/1+*22*%&,3$*/.$',0,(%()$ 5,&Q%"$,#%*,.*%(&/<$.#+*3#.$Q#(5"%$5*(/<$+&Q$'+*-2*$)&,%(-&+$+#T#+-<$*/.$*8-#/)#$ bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the growth and development of pediatric patients.
&1$,#-'&/-#$%&$K9!7$-%(20+*%(&/6$M*/(1#-%*%(&/-$&1$(/%,*),*/(*+$"3'#,%#/-(&/$ the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their 2*/(1#-%*%(&/-$&1$)&,%()&-%#,&(.4,#-'&/-(T#$.#,2*%&-#-6$ (/)+0.#$80+5(/5$1&/%*/#++#-<$"#*.*)"#-<$*/.$8(+*%#,*+$'*'(++#.#2*6$ metabolites are also excreted into the bile.
ADVERSE REATIONS
The following local adverse reactions are reported infrequently with topical corticosteroids, but may $)*(%-&*!&$-(&)*#+
K.2(/(-%,*%(&/$&1$%&'()*+$)&,%()&-%#,&(.-$%&$)"(+.,#/$-"&0+.$8#$+(2(%#.$%&$%"#$+#*-%$ INDICATIONS AND USAGE
occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: 73.,&)&,%(-&/#$H&%(&/$(-$)&/%,*(/.()*%#.$(/$%"&-#$'*%(#/%-$Q(%"$*$"(-%&,3$&1$ Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic "3'#,-#/-(%(T(%3$%&$*/3$&1$%"#$)&2'&/#/%-$&1$%"#$',#'*,*%(&/6$ *2&0/%$)&2'*%(8+#$Q(%"$*/$#11#)%(T#$%"#,*'#0%()$,#5(2#/6$9",&/()$)&,%()&-%#,&(.$ manifestations of corticosteroid-responsive dermatoses.
%"#,*'3$2*3$(/%#,1#,#$Q(%"$%"#$5,&Q%"$*/.$.#T#+&'2#/%$&1$)"(+.,#/6$ CONTRAINDICATIONS
'%"$-3(&)*#+.
-!4"%#".%"-$(&)*#+
Triamcinolone Acetonide Cream is contraindicated in those patients with a history of !"#$1&++&Q(/5$+&)*+$*.T#,-#$,#*)%(&/-$*,#$,#'&,%#.$(/1,#\0#/%+3$Q(%"$%&'()*+$ hypersensitivity to any of the components in the preparation.
O3-%#2()$*8-&,'%(&/$&1$%&'()*+$)&,%()&-%#,&(.-$"*-$',&.0)#.$,#T#,-(8+#$ "3'&%"*+*2()4'(%0(%*,34*.,#/*+$B7IKE$*A(-$-0'',#--(&/<$2*/(1#-%*%(&/-$&1$ )&,%()&-%#,&(.-<$80%$2*3$&))0,$2&,#$1,#\0#/%+3$Q(%"$%"#$0-#$&1$&))+0-(T#$ PRECAUTIONS
.,#--(/5-6$!"#-#$,#*)%(&/-$*,#$+(-%#.$(/$*/$*'',&A(2*%#$.#),#*-(/5$&,.#,$&1$ OVERDOSEAGE
90-"(/5[-$-3/.,&2#<$"3'#,5+3)#2(*<$*/.$5+0)&-0,(*$(/$-&2#$'*%(#/%-6$ Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects Systemic absorption of topical corticosteroids has produced reversible hypothalamic- pituitary adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hypergly- 9&/.(%(&/-$Q"()"$*052#/%$-3-%#2()$*8-&,'%(&/$(/)+0.#$%"#$*''+()*%(&/$&1$%"#$ cemia, and glucosuria in some patients.
DOSAGE AND ADMINISTRATION
2&,#$'&%#/%$-%#,&(.-<$0-#$&T#,$+*,5#$-0,1*)#$*,#*-<$',&+&/5#.$0-#<$*/.$%"#$ Apply to affected area two or three times daily. Rub in gently.
*.(%(&/$&1$&))+0-(T#$.,#--(/5-6$ Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive Occlusive Dressing Technique
!"#,#1&,#<$'*%(#/%-$,#)#(T(/5$*$+*,5#$.&-#$&1$*$'&%#/%$%&'()*+$-%#,&(.$*''+(#.$%&$*$ Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. +*,5#$-0,1*)#$*,#*$&,$0/.#,$*/$&))+0-(T#$.,#--(/5$-"&0+.$8#$#T*+0*%#.$ Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving Therefore, patients receiving a large dose of a potent topical steroid applied to a large a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, '#,(&.()*++3$1&,$#T(.#/)#$&1$7IK$*A(-$-0'',#--(&/$83$0-(/5$%"#$0,(/*,3$1,##$ surface area or under an occlusive dressing should be evaluated periodically for evidence additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before )&,%(-&+$*/.$K9!7$-%(20+*%(&/$%#-%-6$C1$7IK$*A(-$-0'',#--(&/$(-$/&%#.<$*/$*%%#2'%$ of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and the nonporous film is applied or by briefly wetting the affected area with water immediately prior to -"&0+.$8#$2*.#$%&$Q(%".,*Q$%"#$.,05<$%&$,#.0)#$%"#$1,#\0#/)3$&1$*''+()*%(&/<$&,$ for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body applying the medication. The frequency of changing dressings is best determined on an individual )4"%!)#-1"+
temperature occurs, an attempt should be made to withdraw the drug, to reduce the %&$-08-%(%0%#$*$+#--$'&%#/%$-%#,&(.6$ basis. It may be convenient to apply triamcinolone acetonide cream under an occlusive dressing in the !&'()*++3$*''+(#.$)&,%()&-%#,&(.-$)*/$8#$*8-&,8#.$(/$-011()(#/%$*2&0/%-$%&$ frequency of application, substitute a less potent steroid, or use a sequential approach evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the ',&.0)#$-3-%#2()$#11#)%-$BO##$ILG9KN!CWZOE6$ when utilizing the occlusive technique.
12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. L#)&T#,3$&1$7IK$*A(-$10/)%(&/$(-$5#/#,*++3$',&2'%$*/.$)&2'+#%#$0'&/$ Reapplication is essential at each dressing change. If an infection develops, the use of occlusive .(-)&/%(/0*%(&/$&1$%"#$.,056 Recovery of HPA axis function and thermal homeostasis are generally prompt and !)#-1".-*!.-!0&*&#(%-(&)*+
dressings should be discontinued and appropriate antimicrobial therapy instituted.
complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid !&'()*+$)&,%()&-%#,&(.-$*,#$5#/#,*++3$*''+(#.$%&$%"#$*11#)%#.$*,#*$*-$*$%"(/$_+2$ withdrawal may occur, requiring supplemental systemic corticosteroids. Occasionally, a C/1,#\0#/%+3<$-(5/-$*/.$-32'%&2-$&1$-%#,&(.$Q(%".,*Q*+$2*3$&))0,<$,#\0(,(/5$ HOW SUPPLIED
1,&2$%Q&$%&$1&0,$%(2#-$.*(+3$.#'#/.(/5$&/$%"#$-#T#,(%3$&1$%"#$)&/.(%(&/6$ patient may develop a sensitivity reaction to a particular occlusive dressing material or -0''+#2#/%*+$-3-%#2()$)&,%()&-%#,&(.-6$ Triamcinolone Acetonide Cream USP, 0.1%, 30 g (NDC 24338-416-30) tubes.
W))+0-(T#$.,#--(/5-$2*3$8#$0-#.$1&,$%"#$2*/*5#2#/%$&1$'-&,(*-(-$&,$,#)*+)(%,*/%$ adhesive and a substitute material may be necessary.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
9"(+.,#/$2*3$*8-&,8$',&'&,%(&/*++3$+*,5#,$*2&0/%-$&1$%&'()*+$)&,%()&-%#,&(.-$*/.$ Children may absorb proportionally larger amounts of topical corticosteroids and thus be %"0-$8#$2&,#$-0-)#'%(8+#$%&$-3-%#2()$%&A()(%3$BO##$ILG9KN!CWZO4I#.(*%,()$ more susceptible to systemic toxicity (see PRECAUTIONS - Pediatric Use section).
C1$*/$(/1#)%(&/$.#T#+&'-<$%"#$0-#$&1$&))+0-(T#$.,#--(/5-$-"&0+.$8#$.(-)&/%(/0#.$ Mfd. by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: Arbor Pharmaceuticals, Inc., Raleigh, NC 27609 */.$*'',&',(*%#$*/%(2(),&8(*+$%"#,*'3$(/-%(%0%#.6$ If irritation develops, topical corticosteroids should be discontinued and appropriate therapy C1$(,,(%*%(&/$.#T#+&'-<$%&'()*+$)&,%()&-%#,&(.-$-"&0+.$8#$.(-)&/%(/0#.$*/.$ /)5.#3'',&"!+.
In the presence of dermatological infections, the use of an appropriate antifungal or IGJCKJGLM479$B73.,&)&,%(-&/#$H&%(&/$NOI$=PE$(-$-0''+(#.$(/$?$b0(.$&0/)#$ antibacterial agent should be instituted. If a favorable response does not occur promptly, C/$%"#$',#-#/)#$&1$.#,2*%&+&5()*+$(/1#)%(&/-<$%"#$0-#$&1$*/$*'',&',(*%#$*/%(10/5*+$ B=c6d$2HE$.(-'#/-#,$8&%%+#-$BZJ9F$=:;;e4;?d4;>E$*/.$;$2H$'*)S#%-$BZJ9F$ the corticosteroid should be discontinued until the infection has been adequately &,$*/%(8*)%#,(*+$*5#/%$-"&0+.$8#$(/-%(%0%#.6$C1$*$1*T&,*8+#$,#-'&/-#$.&#-$/&%$&))0,$ ',&2'%+3<$%"#$)&,%()&-%#,&(.$-"&0+.$8#$.(-)&/%(/0#.$0/%(+$%"#$(/1#)%(&/$"*-$8##/$ 9KN!CWZF$aGJGLKH$HKf$ILW7C`C!O$JCOIGZOCZY$fC!7WN!$ILGO9LCI!CWZ6 These preparations are not for ophthalmic use.
I*%(#/%-$0-(/5$%&'()*+$)&,%()&-%#,&(.-$-"&0+.$,#)#(T#$%"#$1&++&Q(/5$(/1&,2*%(&/$*/.$ $ $$$$$$$$$$K,8&,$I"*,2*)#0%()*+-<$C/)6$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$L#T6$>cV>c $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$I?:>=6>?

Source: http://arborpharma.com/docs/pediaderm-ta-pi.pdf