MEDPRIDE POVIDONE IODINE SCRUB SOLUTION SKIN CLEANSER- povidone-iodine solution
Shield Line LLC

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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Povidone Iodine Scrub Solution 7.5 %

Active Ingredient

Povidone Iodine, 7.5% (equivalent to .75% available Iodine)

Purpose

Antiseptic

Uses

Washing whenever a germicidal soap is required
Maximum degerming of the hands

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

Apply necessary quantity Degasa Surgical Scrub on area to wash on patients for preoperative or for operating personnel.
Distributing thoroughly Degasa Surgical Scrub on the desired area, rubbing at least 5 minutes.
On patients, rinse off with a sterile gauze saturated with water. On operating personnel, rinse the hands under running water, clean under fingernails use brush if desired.
On operations personnel complete disinfection with another wash with the same way.

Inactive ingredients

Disodium Hydrogen Phosphate,Citric Acid, Purified Water

Principal Display Panel

Principal Display and Drug Fact Panel

MEDPRIDE POVIDONE IODINE SCRUB SOLUTION SKIN CLEANSER
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52410-4116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52410-4116-5	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2019
2	NDC:52410-4116-6	3785 mL in 1 JUG; Type 0: Not a Combination Product	05/14/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/14/2019

Labeler - Shield Line LLC (078518916)