APLICARE POVIDONE-IODINE PREP PAD- povidone-iodine 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 Prep Pad

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Directions

Apply locally as needed.

Other Information

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.

PRINCIPAL DISPLAY PANEL - 10 mg Pad Packet

APLICARE

NDC 52380-4111-1

POVIDONE-IODINE PREP PAD

ANTISEPTIC / Non-Sterile Solution

Reorder No. APLP1111

label aplp11118S

APLICARE POVIDONE-IODINE PREP PAD 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4111
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 (UNII: GR686LBA74)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-4111-10.5 mL in 1 PACKET; Type 0: Not a Combination Product05/31/2017
2NDC:52380-4111-20.5 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. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC081054904manufacture(52380-4111)

Revised: 12/2019
Document Id: 98d09701-b0bf-8f2d-e053-2a95a90a9301
Set id: 3d9b1d83-e5d1-4982-81ab-a7ebedaccc39
Version: 3
Effective Time: 20191203
 
Aplicare, Inc.