Label: FIRST AID DIRECT HAND SANITIZER- hand sanitizer gel

  • NDC Code(s): 42961-123-01, 42961-123-02
  • Packager: Cintas Corporation
  • 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 20, 2023

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl alcohol 66.5%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • for handwashing to decrease bacteria on skin without soap and water
    • recommended for repeated use
  • WARNINGS

    Warnings

    For external use only. 

    Flammable, keep away from fire or flame. 

    Do not use in eyes. If this happens, rinse thoroughly with water. 

    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

    Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands & wrists thoroughly with product and allow to dry without wiping
    • children under 6 years of age should be supervised while using this product
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine 

  • QUESTIONS

    Questions or comments?

    1-800-327-2704 M-F 8 am - 5 pm

  • Principal Display Panel

    HAND SANITIZER GEL

    Ethyl Alcohol 66.5%

    Fresh Scent Instant Hand Sanitizer with Aloe Vera

    SEE BOX OR DRUG FACTS CARD FOR COMPLETE WARNINGS

    USES For hand washing to decrease bateria on skin without soap and water. Recommended for repeated use. 

    DO NOT USE IF PACKET IS TORN OR OPEN. 

    NET WT. 1/32 oz. (0.9g)

    TEAR HERE

    Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    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:42961-123-0210 in 1 BAG07/20/2023
    1NDC:42961-123-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/20/2023
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(42961-123)
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