ANTI-BACTERIAL HAND SANITIZER BLUEBERRY- alcohol gel

Anti-Bacterial Hand Sanitizer by

Drug Labeling and Warnings

Anti-Bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Avon Products, Inc., Avon Cosmetics Manofacturing, S. de R.L. de C.V.. 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

Ethyl Alcohol 64.76%

Purpose

Antiseptic

Uses

Hand washing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

WHEN USING

When using this product

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Avoid contact with broken skin.

STOP USE

Stop use and ask a doctor if irritation and redness develop or 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

• Wet hands thoroughly with product and allow to dry without wiping.
• Children under 6 should be supervised when using this product.

Inactive ingredients

WATER, GLYCERIN, CARBOMER, TRIETHANOLAMINE, HYDROXYPROPYLCELLULOSE, FRAGRANCE, BLUE 1

Questions?

Call 1-800-263-9746

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-BACTERIAL HAND SANITIZER  BLUEBERRY
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71110-0018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	64.76 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71110-0018-1	75 mL in 1 TUBE; Type 0: Not a Combination Product	05/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2020

Labeler - Avon Products, Inc. (222655903)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Cosmetics Manofacturing, S. de R.L. de C.V.		815033493	manufacture(71110-0018)