ADVANCED HAND SANITIZER GEL- alcohol gel

Advanced Hand Sanitizer Gel by

Drug Labeling and Warnings

Advanced Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Sanare Bioscience. 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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For hand washing to decrease bacteria on the skin –recommended for repeated use

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

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 occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center immediately

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision

Other information

Store between 15-30C. Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients

Purified water, hydrogen peroxide, and glycerin , Carbomer

Package Label - Principal Display Panel

236 mL NDC: 78515-002-08

or

3785 mL NDC - 78515-002-28

INGREDIENTS AND APPEARANCE

ADVANCED HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78515-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 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)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	4 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78515-002-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78515-002-28	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78515-002-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Sanare Bioscience (117382399)

Registrant - Sanare Bioscience (117382399)

Establishment
Name	Address	ID/FEI	Business Operations
Sanare Bioscience		117382399	manufacture(78515-002)