NDC Code(s) : 63766-301-01, 63766-301-02, 63766-301-72
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 LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63766-301
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
WATER(UNII: 059QF0KO0R)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
COCONUT OIL(UNII: Q9L0O73W7L)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CETYL ALCOHOL(UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
BETAINE(UNII: 3SCV180C9W)
GLYCERIN(UNII: PDC6A3C0OX)
MANGIFERA INDICA SEED BUTTER(UNII: 4OXD9M35X2)
PADIMATE O(UNII: Z11006CMUZ)
LICORICE(UNII: 61ZBX54883)
AZADIRACHTA INDICA SEED OIL(UNII: 4DKJ9B3K2T)
POLYQUATERNIUM-37 (10000 MPA.S)(UNII: 41QWS48DFN)
LINSEED OIL(UNII: 84XB4DV00W)
PIROCTONE OLAMINE(UNII: A4V5C6R9FB)
CAPRYLIC ACID(UNII: OBL58JN025)
NIGELLA SATIVA SEED OIL(UNII: CS4U38E731)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: O4446S9CRA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW)(UNII: E2KR9C9V2I)
MENTHOL(UNII: L7T10EIP3A)
QUATERNIUM-91(UNII: 00J8H295NB)
PPG-1 TRIDECETH-6(UNII: 1K7417JX6Q)
OREGANO(UNII: 0E5AT8T16U)
BENZYL BENZOATE(UNII: N863NB338G)
SHEA BUTTER(UNII: K49155WL9Y)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
CETRIMONIUM METHOSULFATE(UNII: 277IG2X9QC)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
AMINO ACIDS, HAIR KERATIN(UNII: G46579QK1M)
HYDROLYZED SHEEP WOOL KERATIN (2000 MW)(UNII: NZR037QF7Z)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63766-301-01240 mL in 1 BOTTLE Type 0: Not a Combination Product09/12/2018
2NDC:63766-301-02950 mL in 1 BOTTLE Type 0: Not a Combination Product09/12/2018
3NDC:63766-301-72240 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(63766-301)

PRINCIPAL DISPLAY PANEL

AffirmCare Scalp Therapy
Hydrating Anti-Dandruff Conditioner (8 oz & 32 oz)

Product NDC# 63766-301

Label