Coasstal Hand Sanitizer Gel hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade active ingredient in the preparation of the product (percentage in final product formulation)

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20

Inactive Ingredients

Glycerol (7.6% v/v).
Isopropyl Alcohol ((0.3% v/v)
Hydrogen peroxide (0.1% v/v).
Carbomer (0.4%)
Vitamin E (0.3% v/v)
Sterile distilled water

Label Gallon Bottle with FDA Logo 1 gallon

Active Ingredient(s)

Alcohol 70% 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

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.

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, Isopropyl Alchol, Carbomer, Vitamin E, and purified water USP

Package Label - Principal Display Panel

3785 mL NDC: 79076-900-41

Label Gallon Bottle with FDA Logo 1 gallon

Label Gallon Bottle with FDA Logo 1 gallon Drug Facts

COASTAL HAND SANITIZER GEL
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79076-900
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2649.5 mL in 3785 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)	151.4 mL in 3785 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	113.55 mL in 3785 mL
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	11.355 mL in 3785 mL
GLYCERIN (UNII: PDC6A3C0OX)	287.66 mL in 3785 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	37.85 mL in 3785 mL
WATER (UNII: 059QF0KO0R)	533.685 mL in 3785 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79076-900-41	00 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC:79076-900-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC:79076-900-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
4	NDC:79076-900-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
5	NDC:79076-900-25	9463 mL in 1 BAG; Type 0: Not a Combination Product	07/01/2020
6	NDC:79076-900-27	1040988 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/26/2020

Labeler - U.S. BEVERAGE, INC. (180035917)

Name	Address	ID/FEI	Business Operations
Establishment
U.S. BEVERAGE, INC.		180035917	manufacture(79076-900)