APLICARE POVIDONE-IODINE TRIPLES- povidone-iodine solution

Aplicare Povidone-iodine Triples by

Drug Labeling and Warnings

Aplicare Povidone-iodine Triples 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

Do not use

• if allergic to iodine
• in the eyes

For external use only

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

Avoid pooling beneath patient

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

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
• for single use only

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, 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 - 3 Swabstick Packet

NDC: 52380-5101-3

NPN 02076101

APLICARE

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THREE
POVIDONE-IODINE
SWABSTICKS

ANTISEPTIC
Non-Sterile Solution

Three 4-inch Saturated Swabsticks

Reorder No. S-3111

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE TRIPLES 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-5101
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-5101-3	6.5 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(52380-5101)