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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-iodine 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

Stop use and ask a doctor if

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

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.

OTHER SAFETY INFORMATION

Avoid excessive heat. Store at room temperature.

Directions

Apply locally as needed.

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT

Inactive Ingredients

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

QUESTIONS

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

800-633-5463

PRINCIPAL DISPLAY PANEL

ONE POVIDONE IODINE SWABSTICK

ANTISEPTIC STERILE Solution

Applicator is STERILE if Package is Intact

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE IODINE SWABSTICK 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1101
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1101-4	2 mL in 1 PACKET; Type 0: Not a Combination Product	02/14/2018	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1984	05/01/2020

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-1101)