Label: ALCOHOL DISINFECTANT- 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 April 22, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose:disinfection and sterilization

  • Purpose

    Antiseptic, Hand Sanitizer.

    disinfection and sterilization

  • Use

    helps decrease bacteria on skin.recommended for repeated use.

  • Warnings

    For external use only. Flammable. Keep away from fire or flame.

  • Do not use

    • do not use on children under 6 years old.
    • do not use on open skin wounds.
  • WHEN USING

    • 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

    irritation and redness develop
    condition persists for more tahn 72 hours

  • 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.

    this product is not a substitute for drugs or medical devices.

    keep container tightly closed and store in a well cool ventilated.

  • Other information

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

    water,carbomer940,trolamine

  • Package Label - Principal Display Panel

    300 mL NDC: 300ml 75711-002-01

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75711-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL225 mL  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E) 1.05 mL  in 300 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.6 mL  in 300 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75711-002-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2020
    Labeler - Qingdao Maixing Biotechnology Co.,Ltd (417832907)
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