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  5. Label Information: Aplicare Povidone-iodine

FDA Label for Aplicare Povidone-iodine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aplicare Povidone-iodine Product Label

The following document was submitted to the FDA by the labeler of this product Aplicare Products, Llc. 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



Povidone-iodine


Purpose



Antiseptic


Use



Antiseptic skin preparation


Warnings



Do not use

-if allergic to iodine

-in the eyes

For external use only

Ask a doctor before use if injuries are

-deep or puncture wounds

-serious burns


Otc - Stop Use



Stop use and ask a doctor if

-redness, irritation, swelling or pain persists or increases

-infection occurs

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


Directions



Apply locally as needed.


Inactive Ingredients



citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water


Questions Or Comments?



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