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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0038 Aplicare Povidone Iodine Swabstick

Povidone-iodine 10%

Antiseptic

Antiseptic skin preparation

For external use only

Do not use

• if allergic to iodine

• in the eyes

Avoid excessive heat. Store between 15-30ºC(59-86ºF).

A sk a doctor before use if injuries are

• deep or puncture wounds

• serious burns

Stop use and ask 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

• 1% titratable iodine

• not made with natural rubber latex

• for hospital or professional use only

Inactive ingredients

• disodium phosphate

• glycerin

• hydroxy ethylcellulose

• nonoxynol-10

• simethicone

• water

For questions or comments

800-633-5463

label

APLICARE POVIDONE IODINE SWABSTICK 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0038
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:52380-0038-72 mL in 1 PACKET; Type 0: Not a Combination Product06/01/200305/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/200305/01/2019
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-0038)

Revised: 2/2020
 
Aplicare Products, LLC.