Label: NEW LIFE ADVANCED FORMULA TOPICAL HAND SANITIZER- alcohol spray

  • NDC Code(s): 49681-200-02, 49681-200-08
  • Packager: New Life Products, Inc.
  • 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 February 2, 2023

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  • Drug Facts

  • Active Ingredient

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses • Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

  • WARNINGS

    Warnings • For external use only. Flammable.

    Keep away from heat or flame.

    Do not use • In children less than 2 months of age

    • On open skin wounds.

    Stop use and ask doctor if irritation and redness develops. 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 • Spray enough product on hands to cover completely. 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 15-30 C(59-86 F)
    • Avoid freezing and excessive heat above 40 C(104 F)

  • INACTIVE INGREDIENT

    Inactive ingredients: Purified Water USP, Glycerin, Hydrogen Peroxide.

  • SPL UNCLASSIFIED SECTION

    Kills Germs +

    Helps Reduce The Risk Of Infections

    NON-STERILE SOLUTION

    MADE IN USA

    AFAM CONCEPT, Inc.

    Chicago, IL 60629

    Watford WD24 7GN, UK

    800-262-2326

    www.newlifesanitizer.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    NEW LIFE ADVANCED FORMULA TOPICAL HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49681-200-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
    2NDC:49681-200-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/21/2020
    Labeler - New Life Products, Inc. (117815140)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Life Products, Inc.117815140manufacture(49681-200)
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