ISOPROPYL ALCOHOL solution

Isopropyl Alcohol by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

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 USP grade ingredients in the preparation of the product, consistent with World Health Organization (WHO) recommendations.

The firm does not add other active or inactive ingredients.

Active ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Uses

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.

Package/Label Principal Display Panel - 60mL Bottle

NDC 0168-0907-60

E.FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Isopropyl Alcohol Antiseptic 75% Topical Solution

Hand Sanitizer

Non-sterile Solution

60 mL

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL 
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0907
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 60 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: 0168-0907-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020

Labeler - Fougera Pharmaceuticals Inc. (043838424)

Establishment
Name	Address	ID/FEI	Business Operations
Fougera Pharmaceuticals Inc.		174491316	MANUFACTURE(0168-0907)