APLICARE POVIDONE IODINE- povidone iodine gel 
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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1738 Aplicare Povidone Iodine Gel, 10%

Active ingredient

Povidone-iodine 10%

(equivalent to 1% available iodine)

Purpose

Antiseptic

Use

  • • antiseptic skin preparation
  • • single use when used for patient preoperative skin preparation

Warnings

  • For external use only
  • Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Do not use

  • • in the eyes
  • • on individuals allergic or sensitive to iodine

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

  • • not made with natural rubber latex
  • • for hospital or professional use only

Inactive ingredients

disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

Questions or comments?

1-800-633-5463

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06540 USA

Made in USA

REF: APL82-269

RL17HND

Package Label

Label

APLICARE POVIDONE IODINE 
povidone iodine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1738
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:52380-1738-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199811/06/2022
2NDC:52380-1738-5118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199811/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/199811/06/2022
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2021
Document Id: d2195149-8a70-1445-e053-2995a90aec96
Set id: 3a7874fb-e664-4e2c-b453-1aeee4832add
Version: 8
Effective Time: 20211201
 
Aplicare Products, LLC