Active Ingredient(S)
Isopropyl Alcohol Antiseptic 75% Topical Solution, Hand Sanitizer Non-Sterile Solution
Isopropyl Alcohol
FDA Label NDC 49867-0072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotex Pharmachem Inc. for the product Isopropyl Alcohol (NDC 49867-0072). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 [email protected]
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
Ipa0020200413 (Ipa0020200413)
* Please review the disclaimer below.
