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Setid 96fc24b5 7385 4e01 A969 9f0deacc6db4 Applno 18748 Form Cream Topical Dosage 0 77 - Drug Product Composition: Loprox cream

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$ API Ref.Price (USD/KG) : 332Xls

USFDA APPLICATION NUMBER - 18748 / DOSAGE - CREAM;TOPICAL - 0.77%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ciclopirox olamine(UNII: 50MD4SB4AP)
(ciclopirox - UNII:19W019ZDRJ)
ciclopirox7.7mg in 1

Inactive Ingredients

Ingredient Name
E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.
Glenmark Pharmaceuticals Inc., USA
Medimetriks Pharmaceuticals, Inc.
benzyl alcohol(LKG8494WBH)
cetyl alcohol(936JST6JCN)
coco diethanolamide(92005F972D)  
lactic acid(33X04XA5AT) 
lactic acid, unspecified form(33X04XA5AT) 
LIGHT MINERAL OIL(N6K5787QVP) 
mineral oil(T5L8T28FGP)  
myristyl alcohol(V42034O9PU)
OCTYLDODECANOL(461N1O614Y)
polysorbate 60(CAL22UVI4M)
sorbitan monostearate(NVZ4I0H58X)
STEARYL ALCOHOL(2KR89I4H1Y)
water(059QF0KO0R)