Label: GEL 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 July 26, 2022

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on skin.

  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame.

    Do not use
    • In children less than 2 months of age
    • On open skin wounds

    When using this product avoid mouth, eyes, and ears. In case of contact with eyes, flush with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help and call Poison Control.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age.
  • Other information

    • Store in 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Aloe Vera, Carbomer, D&C Green #5, D&C Yellow #10, Water, Trolamine

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    GEL SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69394-004
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69394-004-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/28/2020
    2NDC:69394-004-0289 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/28/2020
    Labeler - AAkron Rule Corporation (002434389)
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