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 August 12, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame. Do not ingest or inhale.

  • Do not use

    • for children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. Condition persists for more than 72 hours.

  • 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

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

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

    Fragrance (parfum), Glycerin, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoete Crosspolymer, Water

  • Package Label - Principal Display Panel

    HHCO 128oz3.78L, NDC: 75594-006-08

    HHCO 2oz.059L, NDC: 75594-006-01

    HHCO 4oz.12L, NDC: 75594-006-02

    HHCO 12oz.354L, NDC: 75594-006-04

    HHCO 8oz.237L, NDC: 75594-006-03

    HHCO 16oz.477L, NDC: 75594-006-05

    HHCO 32oz.946L, NDC: 75594-006-06

    HHCO 64oz1.89L, NDC: 75594-006-07

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-006(NDC:74221-006)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75594-006-010.059 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
    2NDC:75594-006-020.12 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/12/2020
    3NDC:75594-006-030.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
    4NDC:75594-006-040.354 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
    5NDC:75594-006-050.477 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
    6NDC:75594-006-060.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
    7NDC:75594-006-071.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
    8NDC:75594-006-083.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/12/2020
    Labeler - Commercial Beverage Concepts, LLC (080925174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Commercial Beverage Concepts, LLC080925174relabel(75594-006) , repack(75594-006) , label(75594-006) , pack(75594-006)
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