NDC Code(s) : 61543-1644-5
Packager : CCA Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bikini Zone MEDICATED After Shave Fresh Scent PRAMOXINE HYDROCHLORIDE SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61543-1644
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE(UNII: 88AYB867L5)
(PRAMOXINE - UNII:068X84E056) 		PRAMOXINE HYDROCHLORIDE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
LACTIC ACID(UNII: 33X04XA5AT)
TROLAMINE(UNII: 9O3K93S3TK)
BENZYL ALCOHOL(UNII: LKG8494WBH)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
PEG-25 HYDROGENATED CASTOR OIL(UNII: 0ZNO9PJJ9J)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
HAMAMELIS VIRGINIANA TOP WATER(UNII: NT00Y05A2V)
GINGER(UNII: C5529G5JPQ)
OAT(UNII: Z6J799EAJK)
GLYCERIN(UNII: PDC6A3C0OX)
MENTHOL(UNII: L7T10EIP3A)
SALICYLIC ACID(UNII: O414PZ4LPZ)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61543-1644-51 in 1 CARTON
114 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/01/2013

PRINCIPAL DISPLAY PANEL

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