AFFIRMCARE SCALP THERAPY HYDRATING ANTI-DANDRUFF CONDITIONER- pyrithione zinc  lotion 
Avlon Industries, Inc.

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AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Conditioner

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, Cocos
Nucifera (Coconut) Oil, Betaine, Glycyrrhiza Glabra (Licorice)
Root Powder, Glycerin, Cetyl Alcohol, Quaternium-91,
Cetearyl Alcohol, 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, Polyquaternium-37, PPG-1 Trideceth-6,
Phenoxyethanol, Caprylyl Glycol, Caprylic Acid,
Fragrance/Parfum, Cetrimonium Methosulfate, Ethylhexyl
Dimethyl PABA, Polyacrylamide, Propylene Glycol
Dicaprylate/Dicaprate, Benzyl Benzoate, Limonene, Hexyl
Cinnamal.

Questions or comments?1-800-332-8566

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

Product NDC# 63766-301

Label

AFFIRMCARE SCALP THERAPY  HYDRATING ANTI-DANDRUFF CONDITIONER
pyrithione zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63766-301-01240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/201809/13/2018
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03209/12/2018
Labeler - Avlon Industries, Inc. (121278626)
Establishment
NameAddressID/FEIBusiness Operations
Avlon Industries Inc121278626manufacture(63766-301)

Revised: 2/2024
Document Id: 1285ecdd-80c5-0c13-e063-6394a90afae6
Set id: 75aff8f3-04c4-c66d-e053-2991aa0a02fc
Version: 8
Effective Time: 20240229
 
Avlon Industries, Inc.