Label: DR.BETTER HOMES HAND CLEAN- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 January 19, 2021

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  • ACTIVE INGREDIENT

    Alcohol

  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Triethanolamine, Fragrance

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    For the external use only

  • WARNINGS

    Do not use on the following body parts.
    Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)
    If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

    Symptoms of skin irritation

    Other precautions

    For external use only
    Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
    Be careful not to inhale vapor when using it extensively or for a long time. (If you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur).
    When repeated use on the same site, be careful as the skin may become rough due to degreasing.
    When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.
    Do not use for any other purpose.

  • DOSAGE & ADMINISTRATION

    Put a suitable amount on your hand and rub it well to dry

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DR.BETTER HOMES HAND CLEAN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75615-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75615-0010-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - UI COSMETICS CO., LTD (688362189)
    Registrant - UI COSMETICS CO., LTD (688362189)
    Establishment
    NameAddressID/FEIBusiness Operations
    UI COSMETICS CO., LTD688362189label(75615-0010) , manufacture(75615-0010)
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