HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Foggy Mountain Spirit Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

375 sani back FDA.jpg

375 sani front FDA.jpg

750 sani back FDA.jpg

750 sani front FDA.jpg

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic Refill

Warnings

External use only. Do Not Ingest. Flammable. Keep away from flame. Keep Out Of Reach of Children. Do Not Use In or Near The Eyes. If Conatct Occurs Flush With Water.

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.

Directions

• Place enough product in palm to thoroughly cover your hands. Rub together briskly until dry.
• Supervise children when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water, BITREX (denaturant)

Package Label - Principal Display Panel

375 mL NDC: 74914-001-01

750 mL NDC: 74914-001-02

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74914-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74914-001-01	375 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/01/2020
2	NDC: 74914-001-02	750 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2020

Labeler - Foggy Mountain Spirit Company (117482006)

Establishment
Name	Address	ID/FEI	Business Operations
Foggy Mountain Spirit Company		117482006	manufacture(74914-001)