APLICARE POVIDONE-IODINE- povidone-iodine ointment 
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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0026 Aplicare Povidone-iodine Ointment

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

For external use only

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

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

  • titratable iodine
  • Not made with natural rubber latex
  • for hospital of professsional use only

Inactive ingredients

glycerin, polyethylene glycol, propylene glycol

Manufacturing information

Manufactured in the USA by:

Aplicare Products, LLC.

550 Research Parkway, Meriden, CT 06450 USA

RG18APL

Package Label

Label

APLICARE POVIDONE-IODINE 
povidone-iodine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0026-11 g in 1 PACKET; Type 0: Not a Combination Product07/01/198407/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/198407/01/2022
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 1/2021
Document Id: b8ce14ec-d885-1b6b-e053-2a95a90a0eb5
Set id: d1a1eb78-246c-40b1-855a-4fea6d85de42
Version: 12
Effective Time: 20210113
 
Aplicare Products, LLC