Active ingredient

Povidone Iodine 7.5%

Purpose

Antiseptic

Use

• antiseptic skin preparation
• single use when used for patient preoperative skin preparation and/or preinjection indications

Warnings

For external use only
Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Do not use

• in the eyes
• on individuals allergic or sensitive to iodine

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

apply locally as needed

Other information

• not made with natural rubber latex
• for hospital or professional use only

Inactive ingredients

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Reasearch Pkwy, Meriden, CT 06450 USA

Made in USA

REF: APL82362K

RL17HND

Package Label

Label

APLICARE POVIDONE-IODINE SCRUB
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52380-2802
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-2802-8	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1998

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	01/01/1998

Labeler - Aplicare Products, LLC (081054904)

Registrant - Medline Industries, LP (025460908)

2802 Aplicare Povidone-iodine Scrub