Label: CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER- alcohol gel

  • 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 July 23, 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):

    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.

    1. Glycerol (2.00% v/v).
    2. Carbomer Homopolymer Type C (0.25% v/v).
    3. Sterile distilled water or boiled cold water.

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

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    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 fire or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product 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 or rash occurs. 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.

  • 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

    • 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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, carbomer homopolymer type c, purified water USP

  • Package Label - Principal Display Panel

    Curative Biocentric Antiseptic Hand Sanitizer 2oz60 mL NDC: 77094-400-02

    Curative Biocentric Antispetic Hand Sanitizer 8oz

    236 mL NDC: 77094-400-08

    Curative Biocentric Antiseptic Hand Sanitizer 16.9 oz or 500 ml

    500 mL NDC: 77094-400-16

    Curative Biocentric Antiseptic Hand Sanitizer 1gal or 3785 mL

    3785 mL NDC: 77094-400-01

  • INGREDIENTS AND APPEARANCE
    CURATIVE BIOCENTRIC ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77094-400
    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
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.25 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77094-400-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
    2NDC:77094-400-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
    3NDC:77094-400-16500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
    4NDC:77094-400-013785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/24/2020
    Labeler - Circular Centric, Inc. (117507693)
    Registrant - Circular Centric, Inc. (117507693)
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