NDC Code(s) : 54057-083-42
Packager : Afflink, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AFFEX Foaming Antimicrobial Hand So apChloroxylenol LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54057-083
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL(UNII: 0F32U78V2Q)
(CHLOROXYLENOL - UNII:0F32U78V2Q) 		CHLOROXYLENOL0.003 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
AMMONIUM LAURETH-2 SULFATE(UNII: 698O4Z48G6)
AMMONIUM LAURYL SULFATE(UNII: Q7AO2R1M0B)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIUM XYLENESULFONATE(UNII: 4FZY6L6XCM)
COCO MONOETHANOLAMIDE(UNII: C80684146D)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LACTIC ACID(UNII: 33X04XA5AT)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
JOJOBA OIL(UNII: 724GKU717M)
EDETATE SODIUM(UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
CORN OIL(UNII: 8470G57WFM)
AMMONIUM SULFATE(UNII: SU46BAM238)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54057-083-421250 mL in 1 PACKAGE Type 0: Not a Combination Product15/11/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M505(a)(3) 11/15/2013

LABELER - Afflink, Inc.(023121150)

PRINCIPAL DISPLAY PANEL

product label