APLICARE POVIDONE-IODINE SCRUB- povidone-iodine scrub 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

PURPOSE

Antiseptic

INDICATIONS & USAGE

Antiseptic skin preparation

WARNINGS

For external use only

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

Avoid excessive heat. Store at room temperature.

ASK DOCTOR

Ask a doctor before use if injuries are

• deep wounds
• puncture wounds
• serious burns

Stop use and ask a doctor if

redness, irritation, swelling or pain persists or increases

infection occurs

DO NOT USE

Do not use

if allergic to iodine

in the eyes

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.

DOSAGE & ADMINISTRATION

Directions

use sponges to prep desired area

OTHER SAFETY INFORMATION

Other information

for single use only

not made with natural rubber latex

for hospital or professiona use only

QUESTIONS

For questions or comments

800 633 5463

INACTIVE INGREDIENT

Inactive ingredients

ammonium nonoxynol-4 sulfate

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine scrub solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-0024
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
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: 52380-0024-2	90 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/1992
2	NDC: 52380-0024-1	120 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/1992
3	NDC: 52380-0024-3	120 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/1992

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC		081054904	manufacture(52380-0024)