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  5. Label Information: Major Povidone Iodine

FDA Label for Major Povidone Iodine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL – 1 OZ. TUBE
    16. PRINCIPAL DISPLAY PANEL – 1 OZ. CARTON

Major Povidone Iodine Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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.

Other



DRUG FACTS


Active Ingredient



Povidone Iodine USP10% w/w (available iodine 1%)


Purpose



Antiseptic-germicidal


Uses



for the treatment of:

  • minor wounds
  • infections
  • kills bacteria promptly

Warnings



For external use only.


Do Not Use



  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

When Using This Product



  • Avoid contact with eyes.

Ask A Doctor Before Use If You Have



  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use And Ask A Doctor If



  • redness, irritation or swelling occurs or pain persists

Keep This And All Drugs Out Of The Reach Of Children.



In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Directions



  • apply directly to affected area
  • may be bandaged

Other Information



  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
  • For control no. and expiration date, see carton and/or crimp of tube.
  • Will not stain natural fabrics.
  • Protect from freezing.

Inactive Ingredients



glycerin, PEG-6, PEG-32, propylene glycol


Questions?



Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, Ml 48150 USA

Re-Oder No. 100433 M-101


Principal Display Panel – 1 Oz. Tube



Major® NDC 0904-1102-31

Povidine™

FIRST AID OINTMENT

NET WT. 1 OZ (28.35 g) *Compare to

POVIDINE – IODINE 10% Active Ingredient of

AVAILABLE IODINE 1% Betadine® Ointment

Principal Display Panel – 1 oz. Tube - pov00 0000 01

Principal Display Panel – 1 oz. Tube - pov00 0000 01


Principal Display Panel – 1 Oz. Carton



Major® NDC 0904-1102-31

Povidine™ *Compare to

FIRST AID OINTMENT Active Ingredient of

NET WT. 1OZ (28.35 g) POVIDINE - IODINE 10% Betadine® Ointment

Principal Display Panel – 1 oz. Carton - pov00 0000 02

Principal Display Panel – 1 oz. Carton - pov00 0000 02


* Please review the disclaimer below.