TWO PVP-I SCRUB LARGE WINGED SPONGES- povidone-iodine sponge

TWO PVP-I SCRUB LARGE WINGED SPONGES by

Drug Labeling and Warnings

TWO PVP-I SCRUB LARGE WINGED SPONGES by is a Otc medication manufactured, distributed, or labeled by Changzhou Maokang Medical Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone Iodine 10%w/w

Purpose

Antiseptic

Use

• For preparation prior to surgery
• Helps to reduce bacteria that can potentially cause skin infection.

Warnings

• Do not apply to persons allergic to iodine

Ask a doctor before use if injuries are

• deep wounds
• puncture wounds
• serious burns

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

• Prolonged exposure to wet solution may cause skin irritation.

• Store at room temperature. 

Avoid pooling beneath the patient.

Avoid excessive heat.

For external use only

Keep out of reach of children.

• In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions

• use sponge sticks to prep desired area

Other information

• 1% titratable iodine
• for hospital or professional use only

Inactive ingredients

Nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, anhydrous citric acid, Sodium dodecyl sulfate, purifed water

Package Labeling:

INGREDIENTS AND APPEARANCE

TWO PVP-I SCRUB LARGE WINGED SPONGES 
povidone-iodine sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59050-754
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
NONOXYNOL-10 (UNII: K7O76887AP)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59050-754-12	10 in 1 BOX	06/01/2020
1		2 in 1 POUCH
1		120 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/01/2020

Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)