NDC Code(s) : 62257-012-06, 62257-012-17, 62257-012-10, 62257-012-11, 62257-012-14, 62257-012-55
Packager : ABC Compounding Co., Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

1012 AntimicrobialCHLOROXYLENOL SOAP
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62257-012
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL(UNII: 0F32U78V2Q)
(CHLOROXYLENOL - UNII:0F32U78V2Q) 		CHLOROXYLENOL3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DMDM HYDANTOIN(UNII: BYR0546TOW)
COCO MONOISOPROPANOLAMIDE(UNII: 21X4Y0VTB1)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C RED NO. 40(UNII: WZB9127XOA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62257-012-061 in 1 BOX 05/01/2013
1800 mL in 1 BAG Type 0: Not a Combination Product
2NDC:62257-012-17532 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/01/2013
3NDC:62257-012-101000 mL in 1 CARTRIDGE Type 0: Not a Combination Product05/01/2013
4NDC:62257-012-111000 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/01/2013
5NDC:62257-012-143785 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/01/2013
6NDC:62257-012-55208200 mL in 1 DRUM Type 0: Not a Combination Product05/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 05/01/2013

LABELER - ABC Compounding Co., Inc.(003284353)

Establishment
Name Address ID/FEI Business Operations
ABC Compounding Co., Inc. 003284353 manufacture(62257-012)

PRINCIPAL DISPLAY PANEL

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