APLICARE POVIDONE IODINE- povidone iodine gel

Aplicare Povidone Iodine by

Drug Labeling and Warnings

Aplicare Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC, Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-iodine USP 10%

Antiseptic

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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

Stop use and ask a doctor if

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

ASK DOCTOR

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns
  

QUESTIONS

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

INDICATIONS & USAGE

Use

antiseptic skin preparation

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

DOSAGE & ADMINISTRATION

Directions apply locally as needed.

OTHER SAFETY INFORMATION

Other information

1% titratable iodine

latex free

for professional or professional use only

INACTIVE INGREDIENT

disodium phosphate

glycerin

hydroxyethylcellulose

nonoxynol-10

simethicone

water

PRINCIPAL DISPLAY PANEL

APLICARE

POVIDONE-IODINE GEL

ANTISEPTIC

NON-STERILE SOLUTION

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE IODINE 
povidone iodine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1738
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1738-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	11/06/2022
2	NDC: 52380-1738-5	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/1998	11/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/1998	11/06/2022

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Ashland Chemical (ISP Chemicals LLC)		002188894	api manufacture(52380-1738)

Establishment
Name	Address	ID/FEI	Business Operations
Medline (Hartland)		079800021	manufacture(52380-1738)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-1738) , repack(52380-1738)