Label: SUMMIT 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 June 29, 2020

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  • Drug Facts

  • Active ingredient(s)

    Ethyl Alcohol 70% (V/V%)

    Purpose

    Antiseptic

  • Use[s]

    • To help minimize bacteria on the skin that could cause disease
    • Recommended for repeated use
  • Warnings

    For external use only

    • Flammable

    • Keep away from fire or flame

    Do not use

    • On children less than 2 months of age
    • On open skin wounds

    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 and ask a doctor if

    irritation, rash or redness develops and persists

    Keep out of reach of children

    • If swallowed, seek medical help or contact a Poison Control Center immediately
  • Directions

    • Apply enough product to cover all areas of hands 
    • Rub hands together briskly until dry
    • Children under 6 years of age require supervision when using this product
  • Other information

    • Do not store above 105°F
    • May cause fabric discoloration
    • May harm plastics and wood finishes
  • Inactive Ingredients

    Purified water USP, Glycerol, Hydroxyethylcellulose , Tocopheryl Acetate (Vitamin E), Benzalkonium Chloride, Tetrasodium EDTA, Citric Acid.

  • Package Labeling

    Bottle

  • INGREDIENTS AND APPEARANCE
    SUMMIT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79190-000
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79190-000-015000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/30/2020
    Labeler - IMO SOURCE (PTY) LTD (557388658)
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