Label: HAND SANITIZER- ethyl 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 1, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antimicrobial

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not use in or near eyes. If eye contact occurs, flush thoroughly with water and seek medical care.

    Avoid contact with broken skin.

    Ingestion may cause alcohol poisoning. If ingested, contact a physician or local poison control center.

  • STOP USE

    Stop use and seek medical attention if irritation or redness occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • Pour product in hands.
    • Rub together
    • Let dry
    • For children under 6, use only under adult supervision.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance

  • INDICATIONS & USAGE

    Uses

    • To decrease bacteria on the skin that could cause disease.
    • Recommended for repeated use.
  • Other Information

    Store below 110 F/43 C

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71089-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71089-002-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/09/2017
    Labeler - Germ Guards Incorporated (080329404)
    Registrant - Germ Guards Incorporated (080329404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(71089-002)
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