HAND GEL SANITIZER- alcohol gel

Hand Gel Sanitizer by

Drug Labeling and Warnings

Hand Gel Sanitizer by is a Otc medication manufactured, distributed, or labeled by Allied Pressroom Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is an isopropyl alcohol based hand sanitizer manufactured following the CDC recomendation of using an alcohol concentration of more than 60 % v/v alcohol when soap and water is not available.

It is manufactured by gelling a 70 % isopropyl alcohol solution with the minimum of an acrylate polymer to create a clear gel that is easy to apply and does not evaporate as readiliy as the liquid versions to provide sufficient dwell time to be effective.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product::

1. Alcohol (isopropyl alcohol) (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. Glycerin (1.00 % v/v)..
3. Polypropylene Glycol (1.2 % v/v)..
4. Acrylate Polymer (0.3% v/v).
5. Sterile distilled water or boiled cold water.

No other materials are used.

Active Ingredient(s)

Isopropyl 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

Water, Polypropylene Glycol, glycerin, Acrylate polymer.

Package Label - Principal Display Panel

3785 ml NDC: 78851-444-05

946 ml NDC: 78851-444-04

240 ml NDC: 78851-444-03

120 ml MDC 78851-444-02

105 ml NDC: 78851-444-01 back 105 105 ml NDC: 78851-444-01 front

INGREDIENTS AND APPEARANCE

HAND GEL SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78851-444
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
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)	1.2 mL  in 100 mL
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE) (UNII: PI80E777XB)	0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78851-444-01	105 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2020
2	NDC: 78851-444-02	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2020
3	NDC: 78851-444-03	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2020
4	NDC: 78851-444-04	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2020
5	NDC: 78851-444-05	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2020

Labeler - Allied Pressroom Products (069895618)

Registrant - Allied Pressroom Products (069895618)

Establishment
Name	Address	ID/FEI	Business Operations
Allied Pressroom Products		069895618	manufacture(78851-444)