HAND SANITIZER- alcohol spray 
EXCLAVE HOLDINGS INC.

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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HAND SANITIZER

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

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 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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

189 mL NDC: 78461-0000-4

4oz label

147 mL NDC: 78461-0000-5

5oz label

236 mL NDC: 78461-0000-8

8oz label

946 mL NDC: 78461-0000-2

32oz label

3785 mL NDC: 78461-0000-1

1gal label

HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78461-0000
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:78461-0000-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78461-0000-5147 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78461-0000-8236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78461-0000-2946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:78461-0000-13785 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 - EXCLAVE HOLDINGS INC. (117536775)
Registrant - JOHN SALSMAN (117536775)
Establishment
NameAddressID/FEIBusiness Operations
EXCLAVE HOLDINGS INC.117536775manufacture(78461-0000)

Revised: 5/2020
Document Id: a68e528a-0d89-1580-e053-2995a90aec76
Set id: a68e617a-2509-a2f3-e053-2a95a90a3dbf
Version: 1
Effective Time: 20200526
 
EXCLAVE HOLDINGS INC.