Label: HAKU PINEAPPLE HAND SANITIZER- ethyl 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 June 11, 2020

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  • ACTIVE INGREDIENT

    Ethyl alcohol 70%

  • INACTIVE INGREDIENTS

    Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Aloe barbadensis leaf extract, Fragrance

  • PURPOSE

    ANTISEPTIC

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame
    --------------------------------------------------------------------------------------------------------
    Do not use
    • in children less than 2 months of age
    • on open skin wounds
    --------------------------------------------------------------------------------------------------------
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    --------------------------------------------------------------------------------------------------------
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    • Hand sanitizer to help reduce bacteria that potentially can cause disease.
    • Recommended for repeated use.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
    • Not recommended for infants

  • Other Information

    • Store between 1℃-30℃ (33.8℉-86℉)
    • Avoid freezing and excessive heat above 40℃ (104℉)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of tube

  • INGREDIENTS AND APPEARANCE
    HAKU PINEAPPLE HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78857-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78857-060-0160 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - SRC Company Co., Ltd. (694702525)
    Registrant - SRC Company Co., Ltd. (694702525)
    Establishment
    NameAddressID/FEIBusiness Operations
    C&N COSMETICS CO.,LTD688853696manufacture(78857-060)
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