HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Commercial Beverage Concepts, LLC. 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.

Active Ingredient(s)

Ethyl Alcohol

Purpose

Antiseptic

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 ingest or inhale.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. Condition persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

Fragrance (Parfum), Glycerin, Isopropy Myristate, Polyethylene Glycol/Acrylates Copolymer, Tocopheryl Acetate, Water

Package Label - Principal Display Panel

237 mL NDC: 75594-021-01

355mL NDC: 75594-021-07

473 mL NDC: 75594-021-02

946 mL NDC: 75594-021-03

1.89 L NDC: 75594-021-04

3.78 L NDC: 75594-021-05

208 L NDC: 75594-021-06

1249L NDC: 75594-021-08

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75594-021(NDC:77034-002)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L  in 1 L

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75594-021-01	0.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/28/2020
2	NDC: 75594-021-02	0.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/28/2020
3	NDC: 75594-021-03	0.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/28/2020
4	NDC: 75594-021-04	1.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/28/2020
5	NDC: 75594-021-05	3.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/28/2020
6	NDC: 75594-021-07	0.354 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/28/2020
7	NDC: 75594-021-06	208 L in 1 DRUM; Type 0: Not a Combination Product	07/28/2020
8	NDC: 75594-021-08	1249 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	07/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/28/2020

Labeler - Commercial Beverage Concepts, LLC (080925174)

Establishment
Name	Address	ID/FEI	Business Operations
Commercial Beverage Concepts, LLC		080925174	label(75594-021) , pack(75594-021) , relabel(75594-021) , repack(75594-021)