NDC Code(s) : 63766-300-01, 63766-300-02, 63766-300-72
Packager : Avlon Industries, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AffirmCare Scalp Therapy PYRITHIONE ZINC SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63766-300
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
LIMONENE, (+)-(UNII: GFD7C86Q1W)
BENZYL BENZOATE(UNII: N863NB338G)
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)
AZADIRACHTA INDICA SEED OIL(UNII: 4DKJ9B3K2T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PROPANEDIOL(UNII: 5965N8W85T)
OREGANO(UNII: 0E5AT8T16U)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
BETAINE(UNII: 3SCV180C9W)
DISODIUM LAURETH SULFOSUCCINATE(UNII: D6DH1DTN7E)
COCO MONOISOPROPANOLAMIDE(UNII: 21X4Y0VTB1)
CETYL ALCOHOL(UNII: 936JST6JCN)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
MENTHOL(UNII: L7T10EIP3A)
CETEARETH-60 MYRISTYL GLYCOL(UNII: 4O832ZOY6W)
EDETATE SODIUM(UNII: MP1J8420LU)
GLYCERIN(UNII: PDC6A3C0OX)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
CAPRYLIC ACID(UNII: OBL58JN025)
HYDROLYZED SHEEP WOOL KERATIN (2000 MW)(UNII: NZR037QF7Z)
AMINO ACIDS, HAIR KERATIN(UNII: G46579QK1M)
2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID(UNII: 71X53V3RZ1)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63766-300-01240 mL in 1 BOTTLE Type 0: Not a Combination Product09/12/2018
2NDC:63766-300-02950 mL in 1 BOTTLE Type 0: Not a Combination Product09/12/2018
3NDC:63766-300-72240 mL in 1 TUBE Type 0: Not a Combination Product09/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 09/12/2018

LABELER - Avlon Industries, Inc.(121278626)

Establishment
Name Address ID/FEI Business Operations
Avlon Industries Inc 121278626 manufacture(63766-300)

PRINCIPAL DISPLAY PANEL

AffirmCare Scalp Therapy

Hydrating Anti-Dandruff Shampoo (8 oz & 32 oz)

Product NDC# 63766-300

Label