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Aplicare Total Joint Prep

Dosage form: kit
Ingredients: POVIDONE-IODINE 9.8g in 96.4mL
Labeler: Aplicare, Inc.
NDC Code: 52380-7310

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.

Drug Facts

Active ingredientPovidone-iodine USP

Purpose

Antiseptic

Useantiseptic 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.

Directionsapply 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.



Total Joint Prep Kit

APLICARE TOTAL JOINT PREP  
povidone-iodine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-7310
Packaging
#Item CodePackage Description
1NDC:52380-7310-050 KIT (KIT) in 1 CASE
11 KIT (KIT) in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 6.5 mL
Part 21 PACKET 30 mL
Part 1 of 2
APLICARE POVIDONE-IODINE TRIPLES 
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-3101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE9.8 g  in 96.4 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage Description
1NDC:52380-3101-56.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1998
Part 2 of 2
APLICARE POVIDONE-IODINE  
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE9.8 g  in 96.4 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage Description
1NDC:52380-0001-330 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1984
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/01/2011
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIOperations
Aplicare, Inc.107255002relabel, manufacture

Revised: 03/2012
Document Id: f097e630-cfad-47ce-bb53-3ec07c3d0943
Set id: 4464dd8c-bc39-4b84-bbf5-ee6ffd6b8c6e
Version: 7
Effective Time: 20120306
 
Aplicare, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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