NDC Code(s) : 72474-100-01
Packager : Salon Commodities, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

As I Am PYRITHIONE ZINC SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72474-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC(UNII: R953O2RHZ5)
(PYRITHIONE ZINC - UNII:R953O2RHZ5) 		PYRITHIONE ZINC10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
BETAINE(UNII: 3SCV180C9W)
DISODIUM LAURETH SULFOSUCCINATE(UNII: D6DH1DTN7E)
COCO MONOISOPROPANOLAMIDE(UNII: 21X4Y0VTB1)
CETYL ALCOHOL(UNII: 936JST6JCN)
2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID(UNII: 71X53V3RZ1)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
MENTHOL(UNII: L7T10EIP3A)
CETEARETH-60 MYRISTYL GLYCOL(UNII: 4O832ZOY6W)
EDETATE SODIUM(UNII: MP1J8420LU)
TEA TREE OIL(UNII: VIF565UC2G)
OLIVE OIL(UNII: 6UYK2W1W1E)
GLYCERIN(UNII: PDC6A3C0OX)
CAPRYLIC ACID(UNII: OBL58JN025)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
WATER(UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE(UNII: 518XTE8493)
LINSEED OIL(UNII: 84XB4DV00W)
GLYCOL STEARATE(UNII: 0324G66D0E)
POLYQUATERNIUM-10 (125 MPA.S AT 2%)(UNII: L45WU8S981)
PIROCTONE OLAMINE(UNII: A4V5C6R9FB)
PEPPERMINT OIL(UNII: AV092KU4JH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PROPANEDIOL(UNII: 5965N8W85T)
OREGANO(UNII: 0E5AT8T16U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72474-100-01355 mL in 1 BOTTLE Type 0: Not a Combination Product26/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 07/26/2018

LABELER - Salon Commodities, Inc.(046900541)

REGISTRANT - Avlon Industries Inc(121278626)

Establishment
Name Address ID/FEI Business Operations
Avlon Industries Inc 121278626 manufacture(72474-100)

PRINCIPAL DISPLAY PANEL

As I Am - Dry & Itchy Scalp Care - Olive and Tea Tree Oil Shampoo

12 FL OZ (355 ml)

NDC 72474-100-01

Label