APLICARE POVIDONE-IODINE PAINT- povidone-iodine solution 
Aplicare Products, LLC

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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0101 Aplicare Povidone-Iodine Paint

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

For external use only

Avoid pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Avoid excessive heat. Store at room temperature.

Do not use

  • if allergic to iodine
  • in the eyes

Ask a doctor before use if injuries are

  • deep wounds
  • 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

use sponge sticks to prep desired area

Other information

Inactive ingredients

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

Package Label

label

APLICARE POVIDONE-IODINE PAINT 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0101-52 in 1 PACKAGE03/01/1992
152.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1992
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 11/2021
Document Id: d1f5ab69-0f39-0598-e053-2a95a90a0304
Set id: b66bb4d3-dccf-4fd6-a760-a0b2c22d56bb
Version: 7
Effective Time: 20211129
 
Aplicare Products, LLC