HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Alpha Aromatics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following ingredinets:

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.
5. Fragrance

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

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, hydrogen peroxide, purified water USP, fragrance

Package Label - Principal Display Panel

55 gallon NDC: 75009-280-01

275 gallon NDC: 75009-280-02

5 gallon NDC: 75009-280-03

1 gallon NDC: 75009-280-04

1 quart NDC: 75009-280-05

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75009-280
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)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)	4.45 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75009-280-01	208190 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75009-280-02	1040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020
3	NDC: 75009-280-03	18920 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020
4	NDC: 75009-280-04	3780 mL in 1 JUG; Type 0: Not a Combination Product	03/30/2020
5	NDC: 75009-280-05	946 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 - Alpha Aromatics (041723545)

Establishment
Name	Address	ID/FEI	Business Operations
Alpha Aromatics		041723545	manufacture(75009-280)