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 USP 10%

PURPOSE

Antiseptic

WARNINGS

Warnings

Do not use if allergic to iodine

Do not use in eyes

For external use only

Avoid pooling beneath patient

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases

INDICATIONS & USAGE

Use

antiseptic skin preparation

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

DOSAGE & ADMINISTRATION

Directions apply locally as needed

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.

OTHER SAFETY INFORMATION

Other information

1% titratable iodine

latex free

for hospital or professional 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 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: 52380-1905
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: 52380-1905-2	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	11/06/2022
2	NDC: 52380-1905-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	11/06/2022
3	NDC: 52380-1905-8	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	06/01/2022
4	NDC: 52380-1905-6	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	11/06/2022
5	NDC: 52380-1905-7	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998
6	NDC: 52380-1905-9	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	06/01/2022
7	NDC: 52380-1905-3	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998
8	NDC: 52380-1905-0	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/1998

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/1998

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Medline Industries, Inc.		079800021	manufacture(52380-1905)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC		081054904	manufacture(52380-1905)