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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1101 Aplicare Povidone Iodine Swabstick

Active Ingredient

Povidone-iodine 10%

Purpose

Antiseptic

Use

Antiseptic skin preparation

Warnings

For external use only

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.

Avoid excessive heat. Store at room temperature.

Directions

Apply locally as needed.

Other Information

  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only

Inactive Ingredients

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

For questions, comments, or to report serious side effects:

800-633-5463

label

ONE POVIDONE IODINE SWABSTICK

ANTISEPTIC STERILE Solution

Applicator is STERILE if Package is Intact

APLICARE POVIDONE IODINE SWABSTICK 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1101
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1101-42 mL in 1 PACKET; Type 0: Not a Combination Product02/14/201805/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/198405/01/2020
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-1101)

Revised: 2/2020
 
Aplicare Products, LLC.