Label: DAMOAE THERAPY- pyrithione zinc shampoo

  • 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 July 20, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: PYRITHIONE ZINC

  • INACTIVE INGREDIENT

    Inactive ingredients:

    biotin, Dexpanthenol, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 80, MENTHA PIPERITA LEAF, CITRUS RETICULATA FRUIT OIL,
    ALOE VERA LEAF, FALLOPIA MULTIFLORA ROOT, POLYQUATERNIUM-10 (400 CPS AT 2%), DIMETHICONE, ROSEMARY OIL, OENOTHERA BIENNIS FLOWERING TOP, LEVOMENTHOL,
    1,2-HEXANEDIOL, CAPRYLYL GLYCOL, WATER

  • PURPOSE

    Purpose: Dandruff

  • WARNINGS

    Warnings:

    If side-effects, such as redness, itching or swelling occur, discontinue use. If a irritation continues after discontinuing use, consult a dermatologist.
    If a red area develops using this product or there is swelling or itchiness, consult a dermatologist.
    Exposure to direct sunlight may cause side-effects as above.
    Do not apply product to an area of skin that is affected by eczema or dermatitis.
    Wash eyes immediately and thoroughly if product enters eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    Replace the caps after use.
    Keep away from babies and children.

  • INDICATIONS & USAGE

    Indication and usage:

    Firstly, to wet hair root sufficiently with tepid water. Do pumping proper amount of shampoo, then simply do shampooing. Later, rinse it slightly.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:

    Do pumping enough amount of shampoo. Rub it with finger tip slowly as if you gave a massage for 3-5 minutes, and then rinse it sufficiently with tepid water.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DAMOAE THERAPY 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76081-010
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE - UNII:6GK82EC25D) PYRITHIONE ZINC3 g  in 300 g
    Inactive Ingredients
    Ingredient NameStrength
    biotin (UNII: 6SO6U10H04)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Dexpanthenol (UNII: 1O6C93RI7Z)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    OENOTHERA BIENNIS FLOWERING TOP (UNII: I3Z7321G2F)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76081-010-01300 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/01/2010
    Labeler - DUALLIFE CO., LTD. (690403832)
    Registrant - DUALLIFE CO., LTD. (690403832)
    Establishment
    NameAddressID/FEIBusiness Operations
    DUALLIFE CO., LTD.690403832manufacture