APLICARE POVIDONE-IODINE PREP PAD- povidone-iodine solution

Aplicare Povidone-Iodine Prep Pad by

Drug Labeling and Warnings

Aplicare Povidone-Iodine Prep Pad 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 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Directions

Apply locally as needed.

Other Information

• Prep pad size: 1-1/4" × 1-1/2"
• 1% titratable iodine
• Not made with natural rubber latex
• For hospital or professional use only

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Warnings

• Do not use if allergic to iodine or in the eyes

• For external use only

• Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burns

• Stop use and ask a doctor if infection occurs or if redness, irritation, swelling or pain persists or increases

• 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.

PRINCIPAL DISPLAY PANEL - 10 mg Pad Packet

APLICARE

NDC: 52380-4111-1

POVIDONE-IODINE PREP PAD

ANTISEPTIC / Non-Sterile Solution

Reorder No. APLP1111

INGREDIENTS AND APPEARANCE

APLICARE POVIDONE-IODINE PREP PAD 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-4111
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)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-4111-1	0.5 mL in 1 PACKET; Type 0: Not a Combination Product	05/31/2017
2	NDC: 52380-4111-2	0.5 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, Inc. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC		081054904	manufacture(52380-4111)