APLICARE POVIDONE-IODINE SCRUB- povidone-iodine solution

Aplicare Povidone-iodine Scrub by

Drug Labeling and Warnings

Aplicare Povidone-iodine Scrub 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 7.5%

PURPOSE

Antiseptic

DO NOT USE

Do not use if allergic to iodine

Do not use in eyes

ASK DOCTOR

Ask a doctor before use if injuries are

deep or puncture wounds

serious burns

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

Warnings

For external use only

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

QUESTIONS

Questions or comments?

1 800-760-3236 (Monday - Friday 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

STOP USE

Stop use and ask a doctor if

infection occurs

redness, irritation, or swelling or pain persists or increases

OTHER SAFETY INFORMATION

Other information

0.75% titratable iodine

latex free

for hospital or professional use only

INACTIVE INGREDIENT

Inactive ingredients

ammonium nonoxynol-4 sulfate

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

PRINCIPAL DISPLAY PANEL

APLICARE

POVIDONE-IODINE SCRUB

ANTISEPTIC

NON-STERILE SOLUTION

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-2802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-2802-8	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1998

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

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-2802) , repack(52380-2802)