Label: ALLURE CHEMICALS INSTANT FOAM HAND SANITIZER- 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 October 13, 2020

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  • Drug Facts

  • Active ingredient

    Ethanol Alcohol 70%

  • Purpose

    Antiseptic

  • Uses [s]

    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 use: In children less than 2 months of age and open skin wounds

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

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact 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 15-30°C (59-86°F)

    • Avoid Freezing and excessive heat above 40°C (104°F)

  • Inactive Ingredients:

    Cetaryl alcohol, Propylene glycol, Sodium Lauryl Ether Sulfate

  • SPL UNCLASSIFIED SECTION

    ALCOHOL LIQUID - MEDICAL GRADE

    KILLS 99.9% OF GERMS, COLD AND FLU VIRUSES

    Manufactured and Packaged by

    ALLURE Chemicals

    9650-A Railroad Drive

    El Paso Texas 79924

    www.allurechemicals.com

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    ALLURE CHEMICALS INSTANT FOAM HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78804-777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78804-777-083800 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
    2NDC:78804-777-09250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/13/2020
    Labeler - Allure Chemicals LP (080442496)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Chemicals LP080442496manufacture(78804-777)
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