Providone- Iodine Prep Solution topical antiseptic

Providone- Iodine Prep Solution topical antiseptic

Drug Labeling and Warnings

Drug Details

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POVIDONE-IODINE PREP SOLUTION- povidone-iodine solution 
Cardinal Health

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.

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Providone- Iodine Prep Solution

topical antiseptic

Active ingredient

Povidone-Iodine USP 10%
(equivalent to 1% titratable iodine)

Purpose

Antiseptic / First Aid Antiseptic

Use

  • First aid to help prevent skin infection in minor cuts, scrapes, and burns
  • For preparation of the skin prior to surgery
  • Helps to reduce bacteria that can potentially cause skin infection

Warnings

For external use only

Do not apply to persons allergic to iodine

As a first aid antiseptic

  • Do not use in the eyes or apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
  • Stop use and consult a doctor if the condition persists or gets worse
  • Do not use longer than 1 week unless directed by a doctor

For preoperative patient skin preparation

  • Do not use in the eyes
  • Discontinue use if irritation and redness develop
  • If condition persists for more than 72 hours consult a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

For preparation of the skin prior to surgery

  • Clean the affected area
  • Apply product to the operative site prior to surgery

For first aid antiseptic

  • Clean the affected area
  • Apply a small amount of this product on the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Other information

  • Protect from freezing
  • Avoid excessive heat

Inactive ingredients

Citric Acid, Disodium Phosphate, Glycerin, Polysorbate 80, Sodium Citrate, Deionized Water

Package Label

label

POVIDONE-IODINE PREP SOLUTION 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63517-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63517-350-0648 in 1 CASE
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 63517-350-0724 in 1 CASE
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 63517-350-0824 in 1 CASE
3473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 63517-350-0412 in 1 CASE
4946 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 63517-350-0548 in 1 CASE
559 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/13/2015
Labeler - Cardinal Health (097537435)

Revised: 11/2015
 
Cardinal Health


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