Label: MANNCAVE HAND SANITIZER- alcohol emulsion

  • NDC Code(s): 74248-001-01, 74248-001-02
  • Packager: SpikeWorld Enterprises Inc. dba MannCave Distilling
  • 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 January 2, 2021

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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

    Decreases bacteria on hands

  • Warnings

    Flammable. Keep away from heat or flame. For external use only.

  • WHEN USING

    When using this product keep out of eyes and mouth.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops.

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

  • 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

    • Rub a dime sized drop onto hands
  • 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

    236 mL NDC: 748248-001-02 8 oz hand sanitizer label

    945 mL NDC: 748248-001-01 32oz hand sanitizer label

  • INGREDIENTS AND APPEARANCE
    MANNCAVE HAND SANITIZER 
    alcohol emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74248-001
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74248-001-02236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/202012/31/2023
    2NDC:74248-001-01946 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/202012/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/202012/31/2023
    Labeler - SpikeWorld Enterprises Inc. dba MannCave Distilling (081368747)
    Registrant - SpikeWorld Enterprises Inc. dba MannCave Distilling (081368747)
    Establishment
    NameAddressID/FEIBusiness Operations
    SpikeWorld Enterprises Inc. dba MannCave Distilling081368747manufacture(74248-001)