Label: DAMOAE THERAPY TONIC- salicylic acid solution

  • 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 February 6, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient: Salicylic acid 2%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    L-menthol, Dexpantenol, Citrus Unshiu Peel extract, polygonum multiflorum root extract, Oenothera Biennis Oil, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Polyoxyethylene Hydrogenated Castor Oil, Sodium Citrate Hydrate, Ethanol, Purified Water

  • PURPOSE

    Purpose: Dandruff

  • WARNINGS

    WARNINGS:
    If side-effects, such as redness, itching or swelling occur, discontinue use. If airritation continues after discontinuing use, consult a dermatologist.
    1. If a red area develops using this product or there is swelling or itchyness, consult a dermatologist.
    2. Exposure to direct sunlight may cause side-effects as above.
    3. Do not apply product to an area of skin that is affected by eczema or dermatitis.
    4. 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:
    Damoae Therapy hair tonic on the scalp 3-4 times by shaking finger tips touching the hair, the locals sprinkle with fingerprints on the scalp 3-5 minutes to fully absorb the massage.
    - 1 day , 2 to 3 times as above is used.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Do pumping enough amount of hair tonic (2-3 times). Rub it with finger tip slowly as if you gave a massage for 3-5 minutes.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DAMOAE THERAPY TONIC 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76081-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.4 mL  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    OENOTHERA BIENNIS (UNII: 76UI55V071)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76081-020-01120 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/01/2011
    Labeler - DUALLIFE CO., LTD. (690403832)
    Registrant - DUALLIFE CO., LTD. (690403832)
    Establishment
    NameAddressID/FEIBusiness Operations
    DUALLIFE CO., LTD.690403832manufacture
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