Label: ALLURE CHEMICALS INSTANT HAND SANITIZER- alcohol solution

  • 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 26, 2020

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  • Drug Facts

  • Active Ingredient[s]

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use[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 the eyes, ears, and mouth. In case of contact with eyes, rinse eyes 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

    Glycerin, and purified water USP

  • SPL UNCLASSIFIED SECTION

    MEDICAL GRADE

    KILLS 99.9% OF GERMS, COLD AND FLU VIRUSES

    MADE IN USA

    Manufactured and Packaged by

    ALLURE Chemicals

    9650-A Railroad Drive

    EI Paso Texas 79924

    www.allurechemicals.com

  • Packaging

    IMAGEIMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    ALLURE CHEMICALS INSTANT HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78804-512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78804-512-010.029 L in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    2NDC:78804-512-020.059 L in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    3NDC:78804-512-040.118 L in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    4NDC:78804-512-080.236 L in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    5NDC:78804-512-160.473 L in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    6NDC:78804-512-320.946 L in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    7NDC:78804-512-051.8 L in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    8NDC:78804-512-003.8 L in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2020
    Labeler - Allure Chemicals LP (080442496)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Chemicals LP080442496manufacture(78804-512)
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