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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AffirmCare Scalp Therapy - Hydrating Anti-Dandruff Shampoo

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, Disodium
Laureth Sulfosuccinate, Betaine, Cocamidopropyl Betaine,
Cocamide MIPA, Sodium Cocoyl Isethionate, Cetyl Alcohol,
Melia Azadirachta Seed Oil, Origanum Vulgare Leaf Extract,
Linum Usitatissimum (Linseed) Seed Extract, Camellia
Sinensis Leaf Extract, Menthol, Keratin, Hydrolyzed Keratin,
Glycol Stearate, Glycerin, Piroctone Olamine, Phenoxyethanol,
Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum,
Tetrasodium EDTA, Ceteareth-60 Myristyl Glycol,
Quaternium-80, Polyquaternium-10, Propanediol, Benzyl
Benzoate, Limonene, Hexyl Cinnamal.

Questions or comments? 1-800-332-8566

AffirmCare Scalp Therapy

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

Product NDC# 63766-300

Label

AFFIRMCARE SCALP THERAPY  HYDRATING ANTI-DANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-300
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
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)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
GLYCERIN (UNII: PDC6A3C0OX)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63766-300-01240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/201809/13/2018
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/12/2018
Labeler - Avlon Industries, Inc. (121278626)
Establishment
NameAddressID/FEIBusiness Operations
Avlon Industries Inc121278626manufacture(63766-300)

Revised: 11/2019
Document Id: 972728a8-062e-d35e-e053-2a95a90a9d2f
Set id: 75afe7e4-0895-58ea-e053-2a91aa0a9150
Version: 6
Effective Time: 20191112
 
Avlon Industries, Inc.