ISOPROPYL ALCOHOL solution

Isopropyl Alcohol by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient(s)

Isopropyl Alcohol Antiseptic 75% Topical Solution, Hand Sanitizer Non-Sterile Solution

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. Keep away from open flame and sources of heat.

Do not use

Do not use on children less than 2 months old.

Do not use on open skin wounds.

Ask a doctor before use if

Information required in 201.66(c)(5)(iv)

Ask a doctor or pharmacist before use if

Information required in 201.66(c)(5)(v)

When using this product

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 doctor if

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Other required warnings

Information required in 201.66 (c)(5)(viii)

Pregnancy/Breastfeeding

Information required in 201.66(c)(5)(ix)

Keep out of reach of children

Keep out of reach of children, if swallowed, call 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)

Storage

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, water

Questions

Questions? 1-800-667-4708 or 1-416-401-7780 (follow prompts)

Report adverse reactions to the above numbers or drugsafety@apotex.com

Principal Display Panel

Representative sample of labeling: PRINCIPAL DISPLAY PANEL - DRUM LABEL ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION, HAND SANITIZER NON-STERILE SOLUTION: HANDLING UNIT #: NDC: 49867-0072-0: BATCH NUMBER.: GROSS WT.: MFG. DATE: TARE WT.: RETEST DATE: NET WT.: CONTAINER NO.: STORAGE CONDITION: STORE BETWEEN 15-30C (59-86F): TRANSPORTATION CONDITION: AVOID FREEZING AND EXCESSIVE HEAT ABOUVE 40C (104F): LABEL SERIAL #: MANUFACTURED BY APOTEX PHARMACHEM INC.: MADE IN: CANADA

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL 
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49867-0072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302)	Isopropyl Alcohol	750 g  in 1 kg

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: 49867-0072-0	208 kg in 1 DRUM; Type 0: Not a Combination Product	04/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/13/2020

Labeler - Apotex Pharmachem Inc. (209840537)