Label: ETHYL ALCOHOL- 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 March 17, 2021

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  • Inactive Ingredients

    Water (Aqua), Glycertin, Carbomer, Propylene Glycol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

  • Directions

    Apply small amount ot hands and rub lightly until dry.

    Supervise children in the use of the product.

  • Warnings:

    Flammable. Keep away from fire or flames. For external use only.
    Keep out of reach of children.
    Avoid contact with eyes.
    In case of contact, rinse eyes throroughly with water.
    Stop use and ask a doctor if skin irritation develops.
    If ingested, get medical help or contact a
    Poison Control Centre immediatly.

    Warnings

    Keep out of reach of children.

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Other Information

    Avoid extreme temperatures.

  • Purpose

    Antibacterial

  • Uses

    To decrease bacteria on the skin.

  • Front Label area

    Requires no water or towels.
    Apply small amount to hands and rub lightly until dry.

  • Package Label

    300 ml Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    ETHYL ALCOHOL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52305-001
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.001 mL  in 100 mL
    CARBOMER 934 (UNII: Z135WT9208) 0.28 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 37.307 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52305-001-30300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/17/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/17/2021
    Labeler - Freshorize LTD (424168503)
    Registrant - Freshorize LLC (018206924)
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