Label: BREATHE HAND SANITIZER GEL- 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 October 6, 2020

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  • Active Ingredient(s)

    Ethyl alcohol 70% Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    • to decrease bacteria on the skin that could cause disease.
    • recommended for repeated use
  • Warnings

    For external use only- hands

    Flammable. Keep away from heat or flame

  • WHEN USING

    When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    avoid contact with broken skin. do not inhale or ingest.


  • STOP USE

    Stop use and ask a doctor if irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping.
    • for children under 6 use only under supervision
    • not recommended for infants
  • Other information

    • do not store above 105 F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    water, glycerin, fragrance, carbopol, triethanolamine

  • Package Label - Principal Display Panel

    breathe Hand Sanitizer Gel

    8 FL OZ (236 mL)

    Breathe Hand Santizer

  • INGREDIENTS AND APPEARANCE
    BREATHE HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-010
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-010-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/06/2020
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blue Cross Laboratories, Inc.008298879manufacture(22431-010)
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