Label: AFFIRMCARE SCALP THERAPY HYDRATING ANTI-DANDRUFF CONDITIONER- pyrithione zinc lotion

  • 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: 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 after rinsing Scalp Therapy Hydrating Anti-Dandruff Shampoo by gently massaging into hair and scalp. Rinse well.
  • 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

    Questions or comments?1-800-332-8566

  • PRINCIPAL DISPLAY PANEL

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

    Product NDC# 63766-301

    Label

  • INGREDIENTS AND APPEARANCE
    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 finalpart358H09/12/2018
    Labeler - Avlon Industries, Inc. (121278626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avlon Industries Inc121278626manufacture(63766-301)
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