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Aplicare Povidone-Iodine Prep Pad

Medically reviewed on Jun 1, 2017

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Aplicare, Inc.
NDC Code: 52380-4111

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.

Aplicare Povidone-Iodine Prep Pad

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Directions

Apply locally as needed.

Other Information
  • Prep pad size: 1-1/4" × 1-1/2"
  • 1% titratable iodine
  • Not made with natural rubber latex
  • For hospital or professional use only

Inactive ingredients

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

Warnings

  • Do not use if allergic to iodine or in the eyes

  • For external use only

  • Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burns

  • Stop use and ask a doctor if infection occurs or if redness, irritation, swelling or pain persists or increases

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

  • Avoid excessive heat. Store at room temperature.

PRINCIPAL DISPLAY PANEL - 10 mg Pad Packet

APLICARE

NDC 52380-4111-1
NPN 02076152

POVIDONE-IODINE PREP PAD

ANTISEPTIC / Non-Sterile Solution

Reorder No. P-1011

APLICARE POVIDONE-IODINE PREP PAD 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC 
NONOXYNOL-9 
SODIUM HYDROXIDE 
WATER 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:52380-4111-10.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2017
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIOperations
Aplicare, Inc.107255002manufacture(52380-4111)

 
Aplicare, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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