Label: ALCOHOL DISINFECTANT- alcohol liquid

  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • 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 antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

    purpose:disinfection and antiseptic

  • Use

    Suitable for sterilization and disinfection of the surface of the object and the complete skin of the human body.

  • Warnings

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

  • Do not use

    • do not use on children 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

    stop use and ask a doctor if irritation and redness develop,condition persists for more tahn 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

    this product is for extermal use.apply this product to skin,hands and general objects
    this product is not a substitute for drugs or medical devices
    use with caution;infants, pregnant women and breastfeeding women
    keep out of reach of children,
    do not use on children 6 years old.do not use on open skin wounds

  • Other information

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

    water

  • Package Label - Principal Display Panel

    50 mL NDC: 75711-003-01

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75711-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75711-003-0150 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!