Label: HAND SANITIZER- 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 July 30, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v   

    Purpose

    Antibacterial

  • Uses

    • hand sanitizer to help reduce bacteria on the skin that may cause disease.
  • Drug Facts

  • Warnings

    For external use only. Store below 110°F(43°C)

    Flammable. Keep away from heat or flame.

    When using this product

    • avoid contact with face, eyes and broken skin. If eye contact occurs flush thoroughly with water.

    Stop use and ask a doctor if

    • irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away. Not recommended for infants.

  • Directions:

    wet hands thoroughly with product and rub into skin until dry.

    • For children under 6, use under adult supervision.
  • Other Information:

    May discolor some fabrics, Harmful to wood finishes and plastics.

  • Inactive Ingredients:

    water, aloe barbadensis leaf juice, carbomer, propylene glycol, peg-12 dimethicone, triethanolamine.

  • Package Labeling:

    lABEL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74649-003
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74649-003-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/15/2020
    Labeler - Yiwu Pharmacy Ecomm Business Enterprise Ltd (554491769)
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