Aplicare Povidone Iodine

Aplicare Povidone Iodine

Drug Labeling and Warnings

Drug Details

k">

APLICARE POVIDONE IODINE- povidone iodine gel 
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.

----------

Aplicare Povidone Iodine

Povidone-iodine USP 10%

Antiseptic

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

Do not use if allergic to iodine

For external use only

Do not use in eyes

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

Stop use and ask a doctor if

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

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Questions or comments?
1-800-760-3236 (Mon to Fri 8:30 AM - 5:00 PM EST)

Use

antiseptic skin preparation

single use when used for patient preoperative skin preparation and/or preinjection indications

Directions apply locally as needed.

Other information

1% titratable iodine

latex free

for professional or professional use only

disodium phosphate

glycerin

hydroxyethylcellulose

nonoxynol-10

simethicone

water

APLICARE

POVIDONE-IODINE GEL

ANTISEPTIC

NON-STERILE SOLUTION

52380-1138 PVP Gel

APLICARE POVIDONE IODINE 
povidone iodine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52380-1738
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: 52380-1738-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
2NDC: 52380-1738-5118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/1998
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Ashland Chemical (ISP Chemicals LLC)002188894api manufacture(52380-1738)
Establishment
NameAddressID/FEIBusiness Operations
Medline (Hartland)079800021manufacture(52380-1738)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-1738) , repack(52380-1738)

Revised: 1/2019
 
Aplicare Products, LLC.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.