APLICARE POVIDONE-IODINE- 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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0001 Povidone-Iodine Pouch (sterile)

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

Do not use

  • • if allergic to iodine
  • • in the eyes

Ask 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 cas 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 USA

Made in USA

1-800-633-5463

0917

Package Label

Rev 0917 Front

Rev 0917 Back

Rev V1 RI21APL

APLICARE POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0001
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:52380-0001-130 mL in 1 PACKET; Type 0: Not a Combination Product02/15/201803/31/2020
2NDC:52380-0001-322.5 mL in 1 PACKET; Type 0: Not a Combination Product02/15/201805/31/2025
3NDC:52380-0001-50.5 mL in 1 PACKET; Type 0: Not a Combination Product02/15/201807/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/198405/31/2025
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2022
Document Id: efe371ad-a36a-29ac-e053-2a95a90a95f9
Set id: 6fd83afc-e12f-41d5-a9b4-ad233bd352f2
Version: 21
Effective Time: 20221215
 
Aplicare Products, LLC