Label: ADVANCED 2 IN 1 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 June 4, 2020

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  • ACTIVE INGREDIENT

    Alcohol 70.0%

  • INACTIVE INGREDIENTS

    Water, Carbomer, Aminomethyl Propanol, Aloe Vera Gel, Grapefruit Seed Extract. Green Tea Extract, Butylene Glycol, Disodium EDTA, Phenoxyethanol

  • PURPOSE

    Antiseptic

  • WARNINGS

    For external use only. Flammable. Keep away from heat and 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 medical advice is needed, have the product container or label at hand.
    ■ 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.
    ■ For use when soap and water are not available.
    ■ Recommended for repeated use.

  • Directions

    ■ Place enough product on hands to cover all surfaces. Rub hands together until dry.
    ■ For children under 6, use only under adult supervision
    ■ Avoid direct inhalation of vapors during application (Headaches and irritation to mucous membranes may occur when directly inhaled.)
    ■ This product is intended only for hand sanitizing.
    ■ To prevent drying out and contamination, close the lid completely after use.
    ■ Keep in their original container not to cause accidents nor diminish the integrity of the product.
    ■ Do not use over bandages, castings, etc. ad irritation may occur.

  • Other Information

    Other Information

    ■ Store below 43°C (110°F)
    ■ May discolor certain fabrics or surfaces

  • QUESTIONS

    www.onnaturalusa.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    ADVANCED 2 IN 1 HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74923-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol350 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AminomethylPropanol (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74923-100-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - THE SUN CO.LTD (694433104)
    Registrant - THE SUN CO.LTD (694433104)
    Establishment
    NameAddressID/FEIBusiness Operations
    THE SUN CO.LTD694433104manufacture(74923-100)
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