PREP SOLUTION  TOPICAL ANTISEPTIC MICROBICIDE- povidone-iodine solution 
Degasa SA De CV

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Prep Solution Topical Antiseptic Microbicide

Drug Facts

Active Ingredient

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

Purpose

Antiseptic

Inactive ingredients

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

Uses

Healthcare 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

Do not use:

In the eyes, on deep or puncture wounds, on individuals who are allergic or sensitive to iodine, as a first aid antiseptic longer than one week and in serious burns.

Stop use and ask a doctor if

Irritation and redness develop and if conditions persist for more than 72 hours.

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:

Skin preparation for the skin: 1.Clean the area, 2. Apply product to the operative site prior to surgery.

For first aid antiseptic

1. Clean the affected area, 2. Apply a small amount of the product on the area 1-3 times daily, 3. May be covered with a sterile bandage, 4. If bandaged, let dry first. 

Other information

Store at room temperature 20-25° C (68-77°F). Not made with natural rubber latex.

Questions?

Call: 800-925-4733

Principal Display Panel

Label - PrepSolution 32oz

Package Labeling:

Label

PREP SOLUTION   TOPICAL ANTISEPTIC MICROBICIDE
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67326-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67326-350-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2011
2NDC:67326-350-06118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
3NDC:67326-350-07237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
4NDC:67326-350-08474 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
5NDC:67326-350-04948 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2007
6NDC:67326-350-093785 mL in 1 JUG; Type 0: Not a Combination Product01/01/2007
7NDC:67326-350-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)01/01/2007
Labeler - Degasa SA De CV (812771980)

Revised: 11/2023
Document Id: 097358e0-eaba-c991-e063-6294a90acb81
Set id: dd34cc57-8a8c-4189-b517-61448f961c9e
Version: 6
Effective Time: 20231105
 
Degasa SA De CV