ADVANCED HAND SANITIZER- alcohol liquid

Advanced Hand Sanitizer by

Drug Labeling and Warnings

Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sanare Bioscience, Sonare 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 80% 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. I
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

glycerin, hydrogen peroxide, Lemon Grass Fragrance, purified water USP

Package Label - Principal Display Panel

2 oz (59mL) NDC: 78515-001-02

or

4 oz (118 mL) NDC: 78515-001-04

or

8 oz (236 mL) NDC: 78515-001-08

or

128 oz (3785 mL) NDC: 78515-001-28

INGREDIENTS AND APPEARANCE

ADVANCED HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78515-001
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)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78515-001-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78515-001-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78515-001-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78515-001-28	3785 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
Sonare Bioscience		117382399	manufacture(78515-001)