APLICARE POVIDONE IODINE SWABSTICK- 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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0038 Aplicare Povidone Iodine Swabstick

Active ingredient

Povidone-iodine 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

For external use only

Avoid excessive heat. Store between 15-30ºC(59-86ºF).

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 ingredient

disodium phosphate, glycerin, hydroxy ethylcellulose, nonoxynol-10, simethicone, water

Manufacturing Information

Manufactured by: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093

Made in USA

www.medline.com

1-800-MEDLINE

Aplicare is a registered trademark of Medline Industries, LP

REF: APLS1138

V1 RJ21APL

Package Label

52380-0038 label

APLICARE POVIDONE IODINE SWABSTICK 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0038
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
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
NONOXYNOL-10 (UNII: K7O76887AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0038-72 mL in 1 PACKET; Type 0: Not a Combination Product06/01/200308/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/200308/31/2024
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2022
Document Id: efe32216-7705-52b4-e053-2a95a90a5ac1
Set id: 1b460e41-9ac9-43fe-8166-8e09f70aaa63
Version: 9
Effective Time: 20221215
 
Aplicare Products, LLC