APLICARE TOTAL JOINT PREP- povidone-iodine
Aplicare, Inc.

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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Disco Joint Kit

Active ingredient

povidone-iodine USP

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

Do not use

if allergic to iodine
in the 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
infection occurs

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

1 percent titratable iodine
latex free
for hospital or professional use only

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

1-800-760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

THREE POVIDONE-IODINE SWABSTICKS

Three 4-inch saturated swabsticks

STERILE unless opened or damaged.

3/4 FLUID OUNCE POVIDONE-IODINE SOLUTION

0.75 Fl. oz. (22.5 mL)

STERILE unless opened or damaged.

3/4 Fluid Ounce Povidone-iodine Solution

Total Joint Prep Kit

APLICARE TOTAL JOINT PREP
povidone-iodine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52380-7310

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-7310-0	50 in 1 CASE	12/01/2011	01/01/2015
1		1 in 1 KIT; Type 0: Not a Combination Product

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PACKET	6.5 mL
Part 2	1 PACKET	30 mL

Part 1 of 2

APLICARE POVIDONE-IODINE TRIPLES
povidone-iodine solution

Product Information
Item Code (Source)	NDC:52380-3101
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-3101-5	6.5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/1998

Part 2 of 2

APLICARE POVIDONE-IODINE
povidone-iodine solution

Product Information
Item Code (Source)	NDC:52380-0001
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-0001-3	22.5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/1984

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/01/2011	01/01/2015

Labeler - Aplicare, Inc. (081054904)

Registrant - Medline Industries, LP (025460908)

Revised: 1/2022

Document Id: d66d4d9a-12f5-bad9-e053-2995a90aaff9

Set id: 4464dd8c-bc39-4b84-bbf5-ee6ffd6b8c6e

Version: 8

Effective Time: 20220125

Aplicare, Inc.