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povidone iodine by Major Pharmaceuticals

Medically reviewed on June 25, 2018

Dosage form: solution
Ingredients: POVIDONE-IODINE 100mg in 1mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-1103

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Povidone Iodine Prep

Active ingredient

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Uses
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
  • Healthcare antiseptic for preparation of the skin prior to surgery.
  • Antiseptic cleanser for preparation of skin prior to an infection.

Warnings
  • FOR EXTERNAL USE ONLY

Do not use
  • As a first aid antiseptic for more than 1 week unless directed by a doctor.
  • In the eyes.
  • Over large areas of the body.
  • On individuals who are allergic  or sensitive to iodine.

Ask a doctor before use if you have
  • Deep puncture wounds
  • Animal bites
  • Serious burns

Stop Use
  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.


Directions

As a first aid antiseptic

  • clean affected area
  • apply a small amount of this product to the area1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.

For preoperative patient skin preparation

  • clean area
  • apply to operative site prior to surgery using the applicator

Inactive Ingredient
  • citric acid
  • glycerin
  • sodium citrate
  • tween 80
  • disodium phosphate
  • purified Water

For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Principal Display Panel

NDC 0904-1103-09

Distributed by
Major Pharmaceuticals
Livonia, MI 48150  USA

Povidine Iodine Topical 10% Solution

8 Fl Oz. (236 mL)

POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (Iodine) Iodine100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
WATER 
GLYCERIN 
SODIUM CITRATE 
POLYSORBATE 80 
SODIUM PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:0904-1103-09237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C12/21/2011
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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