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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-iodine

PURPOSE

Antiseptic

ASK DOCTOR

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.

QUESTIONS

For questions, comments, or to report serious side effects:

1 800 760-3236

Monday-Friday 8:30 a.m.- 5:00 p.m. EST

INDICATIONS & USAGE

antiseptic skin preparation

WARNINGS

For external use only

Ask a doctor before use if unjuries are

deep or puncture wounds

serious burns

Avoid pooling beneath patient

INACTIVE INGREDIENT

ammonium nonoxynol-4 sulfate

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

OTHER SAFETY INFORMATION

Other information

0.75% titrable iodine

latex free

for hospital or professional use only

DOSAGE & ADMINISTRATION

Directions apply locally as needed

PRINCIPAL DISPLAY PANEL

APLICARE

POVIDONE-IODINE SCRUB SWABSTICKS

STERILE SOLUTION

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-3102
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: 52380-3102-5	8 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/1984

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1984

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-3102) , repack(52380-3102)