AFFIRMCARE SCALP THERAPY ANTI-DANDRUFF EXFOLIATING MASQUE- pyrithione zinc  lotion 
Avlon Industries, Inc.

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AffirmCare Scalp Therapy - Anti-Dandruff Exfoliating Masque

Active Ingredient

Zinc Pyrithione 1%

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Uses

For the relief of scalp flaking, itching and irritation associated with dandruff and seborrheic dermatitis.

Warnings

Ask a doctor before use if you have a condition that covers a large area of the body.

When Using This Product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredient

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Betaine, Cetearyl Alcohol, Cocos
Nucifera (Coconut) Oil, Cetyl Alcohol, Juglans Regia (Walnut) Shell Powder, Glycerin,
Behentrimonium Chloride, Stearamidopropyl Dimethylamine, Phytosterols,
Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Melia
Azadirachta Seed Oil, Origanum Vulgare Leaf Extract, Nigella Sativa Seed Oil, Linum
Usitatissimum (Linseed) Seed Extract, Camellia Sinensis Leaf Extract, Menthol,
Keratin, Hydrolyzed Keratin, Piroctone Olamine, Panthenol, Polyquaternium-37,
PPG-1 Trideceth-6, Phenoxyethanol, Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum,
Citric Acid, Isostearyl Ethylimidazolinium Ethosulfate, Polyacrylamide, Propylene
Glycol Dicaprylate/Dicaprate, Dipropylene Glycol, Amyl Cinnamal, Benzyl Benzoate,
Limonene, Hexyl Cinnamal.

Questions or comments?1-800-332-8566

AffirmCare Scalp Therapy
Anti-Dandruff Exfoliating Masque (8 oz & 32 oz)

Product NDC# 63766-302

Label

AFFIRMCARE SCALP THERAPY  ANTI-DANDRUFF EXFOLIATING MASQUE
pyrithione zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
OREGANO (UNII: 0E5AT8T16U)  
BENZYL BENZOATE (UNII: N863NB338G)  
SHEA BUTTER (UNII: K49155WL9Y)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)  
HYDROLYZED SHEEP WOOL KERATIN (2000 MW) (UNII: NZR037QF7Z)  
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
ISOSTEARYL ETHYLIMIDAZOLINIUM ETHOSULFATE (UNII: MZE1E3A2ZS)  
JUGLANS REGIA WHOLE (UNII: 87EJ76IO83)  
PANTHENOL (UNII: WV9CM0O67Z)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63766-302-01227 g in 1 JAR; Type 0: Not a Combination Product09/13/2018
2NDC:63766-302-02907 g in 1 JAR; Type 0: Not a Combination Product09/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03209/13/2018
Labeler - Avlon Industries, Inc. (121278626)
Establishment
NameAddressID/FEIBusiness Operations
Avlon Industries Inc121278626manufacture(63766-302)

Revised: 2/2024
Document Id: 1285d269-82e8-ce45-e063-6294a90ade5a
Set id: 75c55e45-16a6-5b97-e053-2a91aa0ae968
Version: 4
Effective Time: 20240229
 
Avlon Industries, Inc.