Label: HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 14, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 62% v/v.

  • Purpose

    Antiseptic

  • Use

    For Hand Sanitizing

  • Warnings

    ■For external use only
    ■Flammable. Keep away from fire or flame
    When using this product
    1 Keep out of eyes. In case of contact with eyes,
    Flush thoroughly with water
    ■Aviod contact with open skin
    ■Do not inhale or ingest
    Stop use and ask a doctor
    ■If skin iritation or redness develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children under 6 Years of age use only under adult supervision
    Not recommended for infants

  • Directions

    ■Wet hands thoroughly with product and allow to
    Dry without wiping

  • Inactive ingredients

    Deionized Water,Carbomer,Triethanolamine,
    Aloe Barbadensis Gel,Fragrance Glycerin,
    Propylene Glycol,Vitamin E.

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74746-001
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74746-001-01200 in 1 CARTON03/30/2020
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - YUYAO WANGCHENG DAILY COMMODITY CO., LTD. (554527592)
    Establishment
    NameAddressID/FEIBusiness Operations
    YUYAO WANGCHENG DAILY COMMODITY CO., LTD.554527592manufacture(74746-001)
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