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

Stop use and ask a doctor if

infection occurs

redness, irritation, swelling or pain persists or increases

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

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.

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

INACTIVE INGREDIENT

Inactive Ingredients

ammonium nonoxynol-4 sulfate

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

DOSAGE & ADMINISTRATION

Directions

apply locally as needed

OTHER SAFETY INFORMATION

Other information

0.75% titratable iodine

latex free

for hospital or professional use only

PRINCIPAL DISPLAY PANEL

APLICARE POVIDONE-IODINE SCRUB ANTISEPTIC

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-4802
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: 52380-4802-8	118 mL in 1 BOTTLE, PLASTIC; 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
Medline Industries, Inc.		079800021	manufacture(52380-4802)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081068252	manufacture(52380-4802)