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

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0011 Povidone-Iodine (nonsterile)

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

Do not use

  • • if allergic to iodine
  • • in the eyes

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.

Directions

apply locally as needed

Other information

Inactive ingredients

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

Manufacturing Information

Manufactured by:

Aplicare Products, LLC.

550 Research Parkway, Meriden, CT 06450

Made in USA

1-800-633-5463

0117

Package Label

front

back1

front3

back3

Rev V1 RI21APL

APLICARE POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0011
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)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0011-130 mL in 1 PACKET; Type 0: Not a Combination Product05/31/201711/30/2025
2NDC:52380-0011-322.5 mL in 1 PACKET; Type 0: Not a Combination Product05/31/201709/30/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00305/31/201709/30/2026
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 10/2023
Document Id: 0801932c-8862-35d8-e063-6294a90a67c1
Set id: b760668f-31be-47fa-9eee-38cb67780e21
Version: 12
Effective Time: 20231018
 
Aplicare Products, LLC