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  5. Label Information: Isopropyl Alcohol

FDA Label for Isopropyl Alcohol

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK DOCTOR IF
    10. OTHER REQUIRED WARNINGS
    11. PREGNANCY/BREASTFEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. STORAGE
    16. INACTIVE INGREDIENTS
    17. QUESTIONS
    18. PRINCIPAL DISPLAY PANEL

Isopropyl Alcohol Product Label

The following document was submitted to the FDA by the labeler of this product Apotex Pharmachem Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 [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

ipa0020200413 - ipa0020200413


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