APLICARE POVIDONE-IODINE SCRUB SMALL WING SPONGE- povidone-iodine scrub solution 
Aplicare, Inc.

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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Aplicare Povidone-iodine Scrub Small Wing Sponge

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

Warnings

Do not use

  • if allergic to iodine
  • in the eyes

Ask a doctor before use if injuries are

  • deep wounds
  • puncture wounds
  • serious burns

Stop use and ask a doctor if

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

For external use only

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

Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

Avoid excessive heat. Store at room temperature.

Directions

use sponges to prep desired area

Other information

Inactive ingredients

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

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 - 4 Sponge Packet

NDC 52380-5124-4

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

FOUR POVIDONE-IODINE SCRUB
SMALL WINGED SPONGES

ANTISEPTIC
Non-Sterile Solution

Four Small Winged Sponges Saturated with
Povidone-Iodine Scrub USP

Reorder No. F-4012

PRINCIPAL DISPLAY PANEL - 4 Sponge Packet
APLICARE POVIDONE-IODINE SCRUB SMALL WING SPONGE 
povidone-iodine scrub solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-5124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-5124-4120 mL in 1 PACKET; Type 0: Not a Combination Product05/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2017
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture(52380-5124)

Revised: 5/2017
Document Id: c1baa608-27fa-4efe-b0a4-b4c1c6c7489e
Set id: 4f8a29aa-8f0f-4c62-8552-54b8bba9a613
Version: 1
Effective Time: 20170531
 
Aplicare, Inc.