APLICARE POVIDONE IODINE SWABSTICK- povidone iodine solution

Aplicare Povidone Iodine Swabstick by

Drug Labeling and Warnings

Aplicare Povidone Iodine Swabstick 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

For external use only

Do not use

• if allergic to iodine
• in the eyes

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

STORAGE AND HANDLING

Avoid excessive heat. Store at room temperature.

Directions

apply locally as needed

Other information

• 1% titratable iodine
• not made with natural rubber latex
• for hospital or professional use only

Inactive ingredients

disodium phosphate, glycerin, hydroxy ethylcellulose, nonoxynol-10, simethicone, water

QUESTIONS

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

800-760-3236

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

PRINCIPAL DISPLAY PANEL - 1 Swabstick Packet

NDC: 52380-5972-1

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

ONE
POVIDONE-IODINE
GEL SWABSTICK

ANTISEPTIC
Non-Sterile Solution

One 4-inch saturated swabstick

Reorder No. S-1148

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE IODINE SWABSTICK 
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-5972
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
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-5972-1	2 mL in 1 PACKET; Type 0: Not a Combination Product	05/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/31/2017

Labeler - Aplicare Products, LLC (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC		081054904	manufacture(52380-5972)