NDC Code(s) : 72474-101-01
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 LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72474-101
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
SODIUM BENZOATE(UNII: OJ245FE5EU)
BEHENTRIMONIUM CHLORIDE(UNII: X7GNG3S47T)
2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID(UNII: 71X53V3RZ1)
WATER(UNII: 059QF0KO0R)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PPG-1 TRIDECETH-6(UNII: 1K7417JX6Q)
OREGANO(UNII: 0E5AT8T16U)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
PROPANEDIOL(UNII: 5965N8W85T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
COCONUT OIL(UNII: Q9L0O73W7L)
GERANIOL(UNII: L837108USY)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
BETAINE(UNII: 3SCV180C9W)
GLYCERIN(UNII: PDC6A3C0OX)
OLIVE OIL(UNII: 6UYK2W1W1E)
TEA TREE OIL(UNII: VIF565UC2G)
PEPPERMINT OIL(UNII: AV092KU4JH)
.BETA.-SITOSTEROL(UNII: S347WMO6M4)
POLYQUATERNIUM-37 (10000 MPA.S)(UNII: 41QWS48DFN)
LINSEED OIL(UNII: 84XB4DV00W)
PIROCTONE OLAMINE(UNII: A4V5C6R9FB)
STEARAMIDOPROPYL DIMETHYLAMINE(UNII: K7VEI00UFR)
CAPRYLIC ACID(UNII: OBL58JN025)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)(UNII: GMR4PEN8PK)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: O4446S9CRA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW)(UNII: E2KR9C9V2I)
MENTHOL(UNII: L7T10EIP3A)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72474-101-01355 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(72474-101)

PRINCIPAL DISPLAY PANEL

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

12 FL OZ (355 ml)

NDC 72474-101-01

Label