HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by One Plastic ATX s de RL de CV, One Plastic ATX S de RL de CV. 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) (70%, 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. Carbopol (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

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

Glycerin, Carbopol, Purified water USP

PRINCIPAL DISPLAY PANEL

150ml NDC: 80354-830-01

300ml NDC: 80354-830-02

500 ml NDC: 80354-830-03

600 ml NDC: 80354-830-04

1000 ml NDC: 80354-830-05

1500 ml NDC: 80354-830-06

3750 ml NDC: 80354-830-07

18750 ml NDC: 80354-830-08

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80354-830
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80354-830-01	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 80354-830-02	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 80354-830-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 80354-830-04	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 80354-830-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 80354-830-06	1500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 80354-830-07	3750 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 80354-830-08	18750 mL in 1 BOTTLE; 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 - One Plastic ATX s de RL de CV (951582748)

Establishment
Name	Address	ID/FEI	Business Operations
One Plastic ATX S de RL de CV		951582748	manufacture(80354-830)