Label: PURE PASSION HAND SANITIZER JUICY WATERMELON- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 4, 2020

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  • ACTIVE INGREDIENT

    Active ingredient(s)                                       Purpose

    Ethyl Alcohol  70%       ...............                 Antiseptic

  • PURPOSE

    • Hand sanitizer to help decrease bacteria on the skin.
  • KEEP OUT OF REACH OF CHILDREN

    Children under 6, use only under adult supervision. Not recommended for infants.

    if swallowed, seek professional assistance or contact a Poison Control Center.

  • INDICATIONS & USAGE

    Place enough product in your palm to thoroughly spread on both hands and rub into skin until dry.

  • WARNINGS

    For external use only: hands
    Flammable. Keep away from fire or flame.

    When using this product, avoid contact with eyes. In case of contact, flush eyes thoroughly with water. Avoid contact with broken skin.

    Stop and consult a doctor if irritation or redness develop. Condition persist for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Other information:

    • Do not store above 105℉
    • May discolr some fabrics
    • Harmful to wood finishes and plastics.
  • INACTIVE INGREDIENT

    Water (Aqua), Glycerin, carbomer, Triethanolamine, Aloe Barbadensis gel Extract, fragrance (Parfum), FD&C Red No. 4

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    PURE PASSION HAND SANITIZER JUICY WATERMELON 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74511-002
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74511-002-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/04/2020
    Labeler - Xiamen Meidai Cross-border E-commerce Co., Ltd. (416003336)
    Registrant - Xiamen Meidai Cross-border E-commerce Co., Ltd. (416003336)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Meidai Cross-border E-commerce Co., Ltd.416003336manufacture(74511-002)
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