Label: ATOREN PREMIUM 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 April 13, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: Ethyl alcohol 70% v/v

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Aloe Barbadensis Gel, Carbomer, FD &C Blue No.1,FD &C Yellow No.5, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate,
    Propylene Glycol, Tocopheryl Acetate, Water.

  • PURPOSE

    Purpose: Hand Sanitizer

  • WARNINGS

    Warnings:

    • Flammable. Keep away from fire or flame.
    • For external use only.
    • When using this product do not use in or near the eyes.
    In case of contact, rinse eyes thoroughly with water.
    • Stop use and ask a doctor if irritation or rash appears and lasts.
    • Keep Out of Reach of Children.
    • Do not eat.
    • If swallowed, get medical help or contact a Poison Control
    Center right away

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:
    Hand sanitizer to help reduce bacteria on the skin

  • Directions

    Directions:
    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using. Not recommended for infants.

  • PACKAGE LABEL - ATOREN PREMIUM HAND SANITIZER 50mL

    Image of container

  • PACKAGE LABEL - ATOREN PREMIUM HAND SANITIZER 500mL

    Image of container

  • INGREDIENTS AND APPEARANCE
    ATOREN PREMIUM HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74775-010
    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
    Water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74775-010-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
    2NDC:74775-010-02500 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - Kcommerce Co.,Ltd (689860484)
    Registrant - Kcommerce Co.,Ltd (689860484)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natuzen Co.,Ltd.688201272manufacture(74775-010)
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