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Prep Solution Topical Antiseptic Microbicide

Dosage form: solution
Ingredients: POVIDONE-IODINE 100mg in 1mL
Labeler: Degasa SA De CV
NDC Code: 67326-350

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.

Prep Solution Topical Antiseptic Microbicide

Active Ingredient

Povidone Iodine, 10% (equivalent to 1% available Iodine)

Purpose

Antiseptic

Uses
  • Health-care antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For External Use Only

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:

  • Apply product to the operative site prior to surgery

As a first aid antiseptic:

  • Clean the affected area
  • Apply a small amount of this product on the area 1-3 times daily

Inactive ingredients

Citric Acid, Sodium Citrate, Glycerin, Tween 80, Disodium Phosphate, Purified Water

Principal Display Panel

PREP SOLUTION  TOPICAL ANTISEPTIC MICROBICIDE
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67326-350
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYSORBATE 80 
CITRIC ACID MONOHYDRATE 
SODIUM CITRATE, UNSPECIFIED FORM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
WATER 
Packaging
#Item CodePackage Description
1NDC:67326-350-0559 mL in 1 BOTTLE
2NDC:67326-350-06118 mL in 1 BOTTLE
3NDC:67326-350-07237 mL in 1 BOTTLE
4NDC:67326-350-08474 mL in 1 BOTTLE
5NDC:67326-350-04948 mL in 1 BOTTLE
6NDC:67326-350-093785 mL in 1 JUG
7NDC:67326-350-1089 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2007
Labeler - Degasa SA De CV (810285445)

 
Degasa SA De CV

Medically reviewed on Nov 19, 2018

Further information

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

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