CAJUN SPIRITS HAND SANITIZER- ethanol liquid

Cajun Spirits Hand Sanitizer by

Drug Labeling and Warnings

Cajun Spirits Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cajun Spirits Distillery, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients[s].

Alcohol 80%v/

Purpose

Anticeptic

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

in children less than 2 months of age

on open skin wounds

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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when 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

Hand Sanitizer Labels

INGREDIENTS AND APPEARANCE

CAJUN SPIRITS HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74152-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	23.659 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.037 mL  in 29.574 mL
WATER (UNII: 059QF0KO0R)	5.449 mL  in 29.574 mL
GLYCEROL FORMAL (UNII: 3L7GR2604E)	0.429 mL  in 29.574 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74152-001-01	29.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
2	NDC: 74152-001-02	59.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
3	NDC: 74152-001-04	118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
4	NDC: 74152-001-06	177.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
5	NDC: 74152-001-08	236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
6	NDC: 74152-001-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
7	NDC: 74152-001-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
8	NDC: 74152-001-05	18927 mL in 1 PAIL; Type 0: Not a Combination Product	03/27/2020
9	NDC: 74152-001-18	1893 mL in 1 JUG; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

Labeler - Cajun Spirits Distillery, LLC (002075890)

Establishment
Name	Address	ID/FEI	Business Operations
Cajun Spirits Distillery, LLC		002075890	manufacture(74152-001)