Aplicare Non-Sterile Povidone-iodine Prep Swabs, 10%

Aplicare Non-Sterile Povidone-iodine Prep Swabs, 10%

Drug Labeling and Warnings

Drug Details

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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

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

antiseptic skin preparation

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

Do not use if allergic to iodine

For external use only

Ask a doctor if injuries are

  • deep or puncture wounds
  • serious burns

Do not use in eyes

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

Apply locally as needed.

disodium phosphate
glycerin

nonoxynol-10

simethicone

water

Stop use and ask a doctor if

infection occurs

redness, irritation, swelling or pain persists or increases

Other information

1% titratable iodine

latex free

for hospital or professional use only

Questions or comments?

1 800 760-3236 (Mon-Fri 8:30 AM - 5:00 PM EST)

52380-1721 PVP Swabs

APLICARE

POVIDONE-IODINE PREP SWABS

ANTISEPTIC

NON-STERILE SOLUTION

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)  
GLYCERIN (UNII: PDC6A3C0OX)  
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: 11/2019
 
Aplicare Products, LLC.


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