PREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE- povidone-iodine solution

Prep Solution by

Drug Labeling and Warnings

Prep Solution by is a Otc medication manufactured, distributed, or labeled by Degasa SA De CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PREP SOLUTION  TOPICAL ANTISEPTIC MICROBICIDE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67326-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67326-350-05	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2011
2	NDC: 67326-350-06	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2007
3	NDC: 67326-350-07	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2007
4	NDC: 67326-350-08	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2007
5	NDC: 67326-350-04	948 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2007
6	NDC: 67326-350-09	3785 mL in 1 JUG; Type 0: Not a Combination Product	01/01/2007
7	NDC: 67326-350-10	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2007

Labeler - Degasa SA De CV (812771980)