APLICARE TOTAL JOINT PREP- povidone-iodine kit

Aplicare Total Joint Prep by

Drug Labeling and Warnings

Aplicare Total Joint Prep by is a Otc medication manufactured, distributed, or labeled by Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DOCTOR

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns
  

STOP USE

Stop use and ask a doctor if

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

KEEP OUT OF REACH OF CHILDREN

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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.

PRINCIPAL DISPLAY PANEL

Total Joint Prep Kit

INGREDIENTS AND APPEARANCE

APLICARE TOTAL JOINT PREP  
povidone-iodine kit

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-7310-0	50 in 1 CASE
1		1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	POVIDONE-IODINE	9.8 g  in 96.4 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-3101-5	6.5 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	POVIDONE-IODINE	9.8 g  in 96.4 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-0001-3	30 mL in 1 PACKET

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

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

Labeler - Aplicare, Inc. (107255002)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare, Inc.		107255002	relabel, manufacture