APLICARE POVIDONE-IODINE- 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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Aplicare Non-Sterile Povidone-iodine Prep Swabs, 10%

Povidone-iodine USP 10%

Antiseptic

• antiseptic skin preparation

• single use when used for patient preoperative skin preparation and/or preinjection indication

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

For external use only.

Do not use

  • in the eye
  • on individuals allergic or sensitive to iodine

Ask doctor before use if injuries are

  • deep or 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.

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

Other information

• Not made with natural rubber latex

• for hospital or professional use only

Questions or comments?

1 800 633 5463

APLICARE

POVIDONE-IODINE PREP SWABS

ANTISEPTIC

NON-STERILE SOLUTION

Label BoxLabel Each

APLICARE POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1721
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
NONOXYNOL-10 (UNII: K7O76887AP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1721-10.65 mL in 1 PACKET; Type 0: Not a Combination Product09/01/199811/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/199811/06/2022
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-1721)

Revised: 12/2019
Document Id: 98f6bc15-0c94-3a6e-e053-2995a90af513
Set id: c1134f2a-ea36-43f7-a4a5-56c306a15eb1
Version: 6
Effective Time: 20191205
 
Aplicare Products, LLC.