MANNCAVE HAND SANITIZER- alcohol emulsion 
SpikeWorld Enterprises Inc. dba MannCave Distilling

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.

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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 this product keep out of eyes and mouth.

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. 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

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)

Revised: 1/2021
Document Id: b7f300c4-565f-6db2-e053-2995a90aaefb
Set id: a21127b5-af31-7b26-e053-2a95a90a12c0
Version: 3
Effective Time: 20210102
 
SpikeWorld Enterprises Inc. dba MannCave Distilling