Label: 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 22, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Antimicrobial

  • Uses:

    - A hand sanitizer to help reduce bacteria on the skin

  • Warnings:

    For External Use Only.

    Flammable.  Keep away from fire or flame or sparks

    When using this product

    do not use in or near eyes.  In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation or rash appears on the skin

    Keep out of reach of children.

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

  • Directions:

    • Place enough to cover both hands in the palm, and rub hands together until dry.
    • Children under 6 years of age should be supervised by adult when applying this product.
  • Other information.

    • Store below 110 ​oF (43 ​o​C)
    • May discolor certain fabrics or surfaces.
  • Inactive Ingredient

    Purified water, Carbomer 940, PEG12 - dimethicone, Propylene glycol, Aloe barbadensis leaf extract, Triethanolamine, Fragrance

  • ​Package Labeling: 74649-000-02

    59mL

  • Package Labeling:74649-000-08

    236mL

  • Package Labeling:74649-000-01

    Label

  • Package Labeling:74649-000-16

    Label2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74649-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74649-000-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    2NDC:74649-000-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    3NDC:74649-000-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    4NDC:74649-000-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/20/2020
    Labeler - Yiwu Pharmacy Ecomm Business Enterprise Ltd (554491769)
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