Label: DENATURED ALCOHOL- ethanol liquid

  • NDC Code(s): 74047-003-03, 74047-003-32
  • Packager: Shantou Kangjie Daily Chemical Industry Co.,Ltd
  • 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 July 8, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Ethyl Alcohol 75% v/v

  • PURPOSE

    Antimicrobial

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria on skin.

  • WARNING

    Flammable liquid - Keep away from heat, spark, electrical, fire or flame.

    Keep out of reach of children.

  • DO NOT USE

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

  • WHEN USING

    When using this product,

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask doctor if irrtation or rash appears and lasts.

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

  • STOP USE

    Stop use and ask doctor if irrtation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Place enough product in your palm to thoroughly spread on both hands.

    Children under 6 years of age should be supervised when using this product.

  • INACTIVE INGREDIENT

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    003-S1003

  • INGREDIENTS AND APPEARANCE
    DENATURED ALCOHOL 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74047-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74047-003-323780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2023
    2NDC:74047-003-0338 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/06/2023
    Labeler - Shantou Kangjie Daily Chemical Industry Co.,Ltd (527128712)
    Registrant - Shantou Kangjie Daily Chemical Industry Co.,Ltd (527128712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shantou Kangjie Daily Chemical Industry Co.,Ltd527128712manufacture(74047-003)
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!