APLICARE POVIDONE-IODINE SCRUB- povidone-iodine scrub 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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0024 Aplicare Povidone-Iodine Scrub

Active ingredient

Povidone-iodine 10%

Purpose

Antiseptic

Use

Antiseptic skin preparation

Warnings

For external use only

Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

Avoid excessive heat. Store at room temperature.

Ask a doctor before use if injuries are

  • deep wounds
  • puncture wounds
  • serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

Do not use

  • if allergic to iodine
  • in the eyes

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions

use sponges to prep desired area

Other information

Questions or comments?

800 633 5463

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 with domestic and foreign materials

1-800-633-5463

REF: ORF22025S

RD18APL

Package Label

label

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine scrub solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0024
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
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:52380-0024-290 mL in 1 PACKET; Type 0: Not a Combination Product07/01/1992
2NDC:52380-0024-1120 mL in 1 PACKET; Type 0: Not a Combination Product07/01/1992
3NDC:52380-0024-3120 mL in 1 PACKET; Type 0: Not a Combination Product07/01/1992
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/1992
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 1/2021
Document Id: b8ce22da-990c-b361-e053-2a95a90a9517
Set id: 6a5e9e6c-f97c-49b6-991f-22a7fe6c2bcf
Version: 6
Effective Time: 20210113
 
Aplicare Products, LLC