Label: WATERMELON HAND SANITIZER- 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 September 7, 2020

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  • Active Ingredient

    Ethyl Alcohol 75% v/v.

  • Purpose

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin that may cause disease. 

  • Warnings

    For external use only. Flammable. Keep away from heat and flame.

  • WHEN USING

    When using this product avoid contat with face, eyes and broken skin. In case of eye contact, flush with plenty of water and seek medical advice. 
    Stop use and ask a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

  • Directions

    Wet hands thoroughly with product and rub into skin until dry. Children 6 years and younger need adult supervision when using this product.

  • Other information

    Store at temperatures below 110 oF (43 oC). 

  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Aminomethyl propanol, Aloe Barbadensis (Aloe Vera) Gel, Tocopheryl Acetate (Vitamin E), FD&C Blue No.1 , FD&C Yellow No.5

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    WATERMELON HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-048-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/28/2020
    Labeler - CLICK PRODUCTS LLC (080766174)
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