APLICARE POVIDONE-IODINE TRIPLES- 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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5101 Aplicare Povidone-iodine Triples

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.

Storage Information

Avoid excessive heat.Store at room temperature.

Directions

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 USA

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

1-800-633-5463

REF: APLS3111

0117

Package Label

PRINCIPAL DISPLAY PANEL - 3 Swabstick Packet

APLICARE POVIDONE-IODINE TRIPLES 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-5101
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
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-5101-36.5 mL in 1 PACKET; Type 0: Not a Combination Product05/31/201711/30/2025
2NDC:52380-5101-225 in 1 BOX05/31/201711/30/2025
26.5 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:52380-5101-1250 in 1 CASE05/31/201711/30/2025
36.5 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC:52380-5101-5500 in 1 CASE05/31/201711/30/2025
46.5 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/201711/30/2025
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 01f27a63-15f8-cee4-e063-6394a90afa3b
Set id: c674b28c-2c8d-43a8-9d6c-ab710e404089
Version: 6
Effective Time: 20230802
 
Aplicare Products, LLC