Label: BE CLEAN ANTISEPTIC HAND GEL- ethyl 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 5, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Ethyl Alcohol 77% v/v

  • PURPOSE:

    Antiseptic

  • INDICATIONS & USAGE

    USES(S): Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • WARNINGS

    WARNINGS: For external use only. Flammable. Keep away from heat 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, ears, mouth, or open orifices. Rinse eyes thoroughly with water and contact a physician if needed. Avoid ingestion.

    STOP USE AND ASK A DOCTOR: If irritation or rash occurs. These may be signs of a serious condition.

    KEEP OUT OF REACH OF CHILDREN: If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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. 

  • STORAGE AND HANDLING

    OTHER INFORMATION: Store between 15-25C (59-77F). Avoid freezing and excessive heat.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Water (Aqua), Propylene Glycol, Glycerin, Isopropyl Myristate, Carbomer, Aminomethyl Propanol.

  • SPL UNCLASSIFIED SECTION

    GEL MAINS ANTI-SEPTIQUE

    ALCOHOL BASED 77%

    100% VEGAN

    CRUELTY FREE

    HIGH SKIN COMPATIBILITY

    CLIMATE COMPENSATED

    Made in USA

    Distributed by Maria Nila Inc. 900 Third Avenue, 29th Floor, New York, New York 10022

    www.marianila.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    BE CLEAN ANTISEPTIC HAND GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79972-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79972-003-10300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/10/2020
    Labeler - Maria Nila Inc. (117067705)
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