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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Povidone-iodine USP 10%

Antiseptic

Warnings

Do not use if allergic to iodine

Do not use in eyes

For external use only

Avoid pooling beneath patient

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling or pain persists or increases

Use

antiseptic skin preparation

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

Directions apply locally as needed

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

Other information

1% titratable iodine

latex free

for hospital or professional use only

citric acid

disodium phosphate

nonoxynol-9

sodium hydroxide

water

Questions or comments?

1 800-760-3236

Monday - Friday

8:30 AM -5:00 PM EST

l-209APLICARE

POVIDONE SOLUTION

ANTISEPTIC

NON-STERILE SOLUTION

APLICARE POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52380-1905
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52380-1905-260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199811/06/2019
2NDC: 52380-1905-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
3NDC: 52380-1905-8240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
4NDC: 52380-1905-6480 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
5NDC: 52380-1905-7960 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
6NDC: 52380-1905-93800 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
7NDC: 52380-1905-390 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
8NDC: 52380-1905-060 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/1998
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Medline Industries, Inc.079800021manufacture(52380-1905)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC081054904manufacture(52380-1905)

Revised: 11/2019
 
Aplicare Products, LLC.


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