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 USP 7.5%

PURPOSE

Antiseptic

Use

antiseptic skin preparation

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

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

Stop use and ask doctor if

redness, irritation, swelling or pain persists or increases

infection occurs

WARNINGS

For external use only

Avoid "pooling" beneath patient

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 apply locally as needed

OTHER SAFETY INFORMATION

Other information

0.75% titratable iodine

latex free

for hospital or professional use only

Inactive ingredients

ammonium nonoxynol-4 sulfate, disodium phosphate, hydroxyethylcellulose, nonoxynol-9 phosphate, nonoxynol-10, polyoxyethylene nonylphenyl ether phosphate, water

QUESTIONS

Questions or comments?

1800 760-3236 (Monday - Friday 8:30 AM - 5:00 PM EST)

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: 52380-1855
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)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1855-2	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	11/06/2022
2	NDC: 52380-1855-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
3	NDC: 52380-1855-8	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	06/01/2021
4	NDC: 52380-1855-6	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	11/06/2022
5	NDC: 52380-1855-3	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/20/2018	06/01/2021
6	NDC: 52380-1855-7	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	06/01/2021
7	NDC: 52380-1855-9	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	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

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-1855)