Label: FRESH N PURE HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 February 11, 2021

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  • Active Ingredient:

    Ethyl Alcohol 70% v/v

    Purpose:

    Antimicribial

  • Uses:

    Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings:

    Flammable. Keep away from fire or flames.

    When using this product 

    do not use in or near eyes. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor 

    if irritation or rash appears and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison control Center right away.

  • Directions:

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using sanitizer.
  • Other Information:

    • Store below 110°F (43°C) 
    • May discolor some fabrics or surfaces.
  • Inactive Ingredients:

    Purified Water(Aqua), Carbomer, Glycerin, Propylene Glycol, Isopropyl Alcohol, Fragrance (Lemon), Triethanolamine

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    FRESH N PURE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81501-000
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81501-000-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/04/2021
    Labeler - Sai Water & Technology Solution LLC (117138209)
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