APLICARE POVIDONE-IODINE SCRUB 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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4125 Aplicare ® Povidone-iodine Scrub Triples

Active ingredient

Povidone-iodine USP 7.5%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

  • For external use only
  • Avoid pooling beneath the patient

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

  • 0.75% titratable iodine
  • for single use only
  • not made with natural rubber latex
  • for hospital or professional use only

Storage Information

Avoid excessive heat. Store at room temperature.

Inactive ingredients

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Pkwy, Meriden CT 06450 USA

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield IL 60093

1-800-633-5463

0117

REF: S-3112

Package Label

PRINCIPAL DISPLAY PANEL - 3 Swabstick Packet

APLICARE POVIDONE-IODINE SCRUB TRIPLES 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-4125-38 mL in 1 PACKET; Type 0: Not a Combination Product05/31/201712/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/201712/31/2021
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2021
Document Id: d27dbe21-30b9-0a11-e053-2995a90a6489
Set id: a1fe4918-6181-4564-a472-10ccc32fe370
Version: 3
Effective Time: 20211206
 
Aplicare Products, LLC