NDC Code(s) : 72474-103-01
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 EMULSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72474-103
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 g
Inactive Ingredients
Ingredient Name Strength
POLYQUATERNIUM-37 (10000 MPA.S)(UNII: 41QWS48DFN)
LINSEED OIL(UNII: 84XB4DV00W)
PIROCTONE OLAMINE(UNII: A4V5C6R9FB)
STEARAMIDOPROPYL DIMETHYLAMINE(UNII: K7VEI00UFR)
CAPRYLIC ACID(UNII: OBL58JN025)
CETRIMONIUM CHLORIDE(UNII: UC9PE95IBP)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: O4446S9CRA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL(UNII: S347WMO6M4)
POLYACRYLAMIDE (10000 MW)(UNII: E2KR9C9V2I)
MENTHOL(UNII: L7T10EIP3A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PPG-1 TRIDECETH-6(UNII: 1K7417JX6Q)
OREGANO(UNII: 0E5AT8T16U)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
POLYSORBATE 60(UNII: CAL22UVI4M)
QUATERNIUM-18(UNII: O7757NO1VL)
PROPANEDIOL(UNII: 5965N8W85T)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
WATER(UNII: 059QF0KO0R)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
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)
POLIDOCANOL(UNII: 0AWH8BFG9A)
STEARDIMONIUM HYDROXYPROPYL PEG-7 DIMETHICONE PHOSPHATE CHLORIDE(UNII: 7PDD38B23D)
CERAMIDE NG(UNII: C04977SRJ5)
CETEARETH-25(UNII: 8FA93U5T67)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
SODIUM COCOYL ISETHIONATE(UNII: 518XTE8493)
SODIUM LAUROYL GLUTAMATE(UNII: NCX1UU2D33)
PEG-3 DISTEARATE(UNII: 8420ECX438)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SODIUM BENZOATE(UNII: OJ245FE5EU)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72474-103-01454 g in 1 JAR 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(72474-103)

PRINCIPAL DISPLAY PANEL

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

16 OZ (454g)

NDC 72474-103-01

Label