Label: CARE BEARS- 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 May 14, 2020

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  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable Keep away from Flames.

    When using this product Keep out of eyes. In case of contact with eyes, nose eyes Thoroughly with water.

    Avoid contact with broken skin.

    Do not inhale or ingest.

    Stop use and contact a doctor if irritation develops or persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children. If swallowed get immediate medical help or contact a poison control center right away.

  • Directions

    Apply onto hands/skin, rub until dry.

  • Inactive ingredients

    Water, Triethanolamine, Carbomer, Aloe Vera Gel, Glycerin, Propylene Glycol. Vitamin E

  • Package Label - Principal Display Panel

    Label 60 mL

    60 mL Label

  • INGREDIENTS AND APPEARANCE
    CARE BEARS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77706-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77706-002-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/13/2020
    Labeler - BRAND PARTNERS GROUP (046559163)
    Establishment
    NameAddressID/FEIBusiness Operations
    iHotel Guest Amenities Co., Ltd421299845manufacture(77706-002)
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