APLICARE POVIDONE-IODINE- povidone-iodine solution

Aplicare Povidone-Iodine by

Drug Labeling and Warnings

Aplicare Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC, Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-iodine 10%

PURPOSE

Antiseptic

WARNINGS

Warnings

Do not use if allergic to iodine

For external use only

Do not use in the eyes

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns

Stop use and ask a doctor if

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

Avoid pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.

INDICATIONS & USAGE

antiseptic skin preparation

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

DOSAGE & ADMINISTRATION

Directions apply locally as needed

OTHER SAFETY INFORMATION

Other information

1% titratable iodine

latex free

for hospital use only

INACTIVE INGREDIENT

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

QUESTIONS

Questions or comments?

1 800-760-3236 (Monday - Friday 8:30 AM - 5:00 PM EST)

PRINCIPAL DISPLAY PANEL

APLICARE

POVIDONE-IODINE SOLUTION

ANTISEPTIC

NON-STERILE SOLUTION

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-2801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-2801-8	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1998

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1998

Labeler - Aplicare Products LLC (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Medline Industries, Inc.		079800021	manufacture(52380-2801)