APLICARE POVIDONE-IODINE SCRUB- 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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3102 Aplicare Povidone-iodine Scrub

Active ingredient

Povidone-iodine 7.5%

Purpose

Antiseptic

Use

  • antiseptic skin preparation

Warnings

  • For external use only
  • Avoid pooling beneath patient
  • 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

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

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

Made in USA

1-800-633-5463

REF: APLS3102

1114

Package Label

52380-3102 PVP Swabsticks

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-3102
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:52380-3102-58 mL in 1 PACKET; Type 0: Not a Combination Product01/01/198409/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/198409/30/2019
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2021
Document Id: d22c5d94-57b2-529f-e053-2995a90a5674
Set id: 3877eb20-37a7-4726-b6f3-722a8c24c8b6
Version: 5
Effective Time: 20211202
 
Aplicare Products, LLC