0111 Aplicare Povidone-Iodine Prep Pad

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, Aplicare Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

APLICARE POVIDONE-IODINE PREP PAD- povidone-iodine solution 
Aplicare Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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0111 Aplicare Povidone-Iodine Prep Pad

Active Ingredient

Povidone-iodine

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 wounds

- puncture wounds

- serious burns

Stop use and ask a doctor if

- infection occurs

- 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.

Avoid excessive heat.

Store at room temperature.

Directions

Apply locally as needed.

Other information

• 1% titratable iodine
• Latex free
• For hospital or professional use only

Inactive Ingredients

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

APLICARE

POVIDONE-IODINE PREP PAD

ANTISEPTIC

STERILE SOLUTION

APLICARE POVIDONE-IODINE PREP PAD 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-0111
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: 52380-0111-1	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/20/2018	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2015	04/01/2020

Labeler - Aplicare Products, LLC (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-0111)

Revised: 2/2020

Document Id: 9daf41ee-3be8-5836-e053-2a95a90ab993

34390-5

Set id: 11a60f9d-e529-424c-e054-00144ff8d46c

Version: 5

Effective Time: 20200203

 

Aplicare Products, LLC