Label: ADVANCED 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 June 10, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For hand washing to decrease bacteria on the skin - recommended for repeated use.

  • 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
  • WHEN USING

    Keep out of eyes, ears, and mouth.
    In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation occurs. These may be
    signs of a serious condition. Keep out of reach of children. I
    swallowed, get medical help immediately or contact a Poison
    Control Center immediately

  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands thoroughly with product, and allow to
    dry without wiping. For children under six, use only under
    adult supervision

  • Other information

    - Store between 15-30C. Avoid freezing and
    excessive heat above 40C (104F). May discolor some fabrics.
    Harmful to wood finishes and plastics

  • Inactive ingredients

    glycerin, hydrogen peroxide, Lemon Grass Fragrance, purified water USP

  • Package Label - Principal Display Panel

    Package.Label Principal Display Panel2 oz (59mL) NDC: 78515-001-02

    or

    4 oz (118 mL) NDC: 78515-001-04

    or

    8 oz (236 mL) NDC: 78515-001-08

    or

    128 oz (3785 mL) NDC: 78515-001-28

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78515-001
    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
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78515-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:78515-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    3NDC:78515-001-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    4NDC:78515-001-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Sanare Bioscience (117382399)
    Registrant - Sanare Bioscience (117382399)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sonare Bioscience117382399manufacture(78515-001)
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