ISOPROPYL ALCOHOL ANTISEPTIC 75% solution

Isopropyl Alcohol Antiseptic 75% by

Drug Labeling and Warnings

Isopropyl Alcohol Antiseptic 75% by is a Otc medication manufactured, distributed, or labeled by ANI Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient[s]

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Use[s]

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 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.

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° to 30°C (59° to 86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Questions or comments?

1-800-308-6755

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
 
10333 Rev 04/20

Package/Label Principal Display Panel

NDC 62559-960-10
Isopropyl Alcohol Antiseptic 75%
Topical Solution
Hand Sanitizer
Non-sterile Solution
For use during Coronavirus Disease 2019 (COVID-19) pandemic only. Discard once normal supply has resumed.
Not for retail sale or distribution.
Net Contents: 1,000 mL

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL ANTISEPTIC 75% 
isopropyl alcohol antiseptic 75% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62559-960
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62559-960-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

Labeler - ANI Pharmaceuticals, Inc. (145588013)