CURITY 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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3191 Curity Povidone-Iodine Paint

Active ingredient

Povidone-iodine USP 10 percent

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

Do not use if allergic to iodine.

For external use only.

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Do not use in eyes.

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

Stop use and ask a doctor if

  • infection occurs
  • 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.

Directions

  • apply locally as needed

Inactive ingredients

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

Povidone Iodine Paint

CURITY POVIDONE-IODINE PAINT 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-3191
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE9.5 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-3191-888 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/201807/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/199807/01/2021
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC081054904manufacture(52380-3191)

Revised: 1/2020
Document Id: 9d20ef2b-b3ca-f54f-e053-2a95a90a216d
Set id: be49b89e-ded8-447a-877f-4b22faab701b
Version: 3
Effective Time: 20200127
 
Aplicare Products, LLC.