HAND SANITIZER (alcohol- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Western Acceptance, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Gel 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

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

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

• 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

purified water USP,glycerin, hydrogen peroxide, carbomer, triethanolamine

Package Label - Principal Display Panel

3785.41 ml NDC: 80206-020-02

1879.71 ml NDC: 80206-020-01

500 ml NDC: 80206-020-03

250ml NDC: 80206-020-04

118.294 ml NDC: 80206-020-05

88.2706 ml NDC: 80206-020-06

100 ml NDC: 80206-020-07

65.0618 ml NDC: 80206-020-08

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol (ethyl alcohol) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80206-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	26 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80206-020-01	1879.71 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 80206-020-02	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
3	NDC: 80206-020-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
4	NDC: 80206-020-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
5	NDC: 80206-020-05	118.294 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
6	NDC: 80206-020-06	88.7206 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
7	NDC: 80206-020-07	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
8	NDC: 80206-020-08	65.0618 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - Western Acceptance, LLC (117410424)

Registrant - Western Acceptance, LLC (117410424)

Establishment
Name	Address	ID/FEI	Business Operations
Western Acceptance, LLC		117410424	manufacture(80206-020)