Label: AFFIRMCARE SCALP THERAPY HYDRATING ANTI-DANDRUFF- pyrithione zinc shampoo

  • 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: OTC monograph final

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.

Drug Label Information

Updated November 16, 2022

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  • 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

    • For external use only.
  • ASK DOCTOR

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

  • When Using This Product

    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • Condition worsens or does not improve with regular use.
  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • For best results, use at least twice a week, or as directed by a doctor.
    • Shake well before use.
    • Apply by massaging onto wet hair and scalp.
    • Rinse and repeat. Follow with Scalp Therapy Hydrating Anti-Dandruff Conditioner.
  • 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

    Questions or comments? 1-800-332-8566

  • PRINCIPAL DISPLAY PANEL

    AffirmCare Scalp Therapy

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

    Product NDC# 63766-300

    Label

  • INGREDIENTS AND APPEARANCE
    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)  
    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 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)
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