FOUR FATHERS DISTILLERY ALCOHOL ANTISEPTIC 80%- alcohol solution

Four Fathers Distillery by

Drug Labeling and Warnings

Four Fathers Distillery by is a Otc medication manufactured, distributed, or labeled by Four Fathers Distillery LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

Use(s)

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

On children less than 2 months of age  On open skin wounds

When using this product keep out of 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 serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact 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 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

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80%/ Topical Solution

Hand Sanitizer/ Non-Sterile Solution

904-710-6150

Packaging

INGREDIENTS AND APPEARANCE

FOUR FATHERS DISTILLERY  ALCOHOL ANTISEPTIC 80%
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78829-100
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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78829-100-38	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020

Labeler - Four Fathers Distillery LLC (085564625)

Establishment
Name	Address	ID/FEI	Business Operations
Four Fathers Distillery LLC		085564625	manufacture(78829-100)