Label: SANTIGEL- hand sanitizer gel 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 May 11, 2022

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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

    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
    • 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, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    475 mL NDC: 74786-000-04

    475 mL Label

    60mL NDC: 74786-000-01

    60 mL Label

    120mL NDC: 74786-000-02

    120 mL Label 240mL NDC: 74786-000-03

    240 mL Label 3785mL NDC: 74786-000-05

    3785 mL Label

  • INGREDIENTS AND APPEARANCE
    SANTIGEL 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74786-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E) 4.5 mL  in 1000 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 1000 mL
    WATER (UNII: 059QF0KO0R) 195 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74786-000-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:74786-000-02120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:74786-000-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:74786-000-04475 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:74786-000-053785 mL in 1 BOTTLE; 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 - NicVape, Inc. (078681796)
    Registrant - NicVape, Inc. (078681796)
    Establishment
    NameAddressID/FEIBusiness Operations
    NicVape, Inc.078681796manufacture(74786-000)
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