Aplicare Povidone-iodine Scrub

Aplicare Povidone-iodine Scrub

Drug Labeling and Warnings

Drug Details

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APLICARE POVIDONE-IODINE SCRUB- 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 Povidone-iodine Scrub

Povidone-iodine USP 7.5%


Antiseptic

Use

antiseptic skin preparation

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

Do not use if allergic to iodine

Do not use in eyes

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Stop use and ask doctor if

redness, irritation, swelling or pain persists or increases

infection occurs

For external use only

Avoid "pooling" beneath patient

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

Directions apply locally as needed

Other information

0.75% titratable iodine

latex free

for hospital or professional use only

Inactive ingredients

ammonium nonoxynol-4 sulfate, disodium phosphate, hydroxyethylcellulose, nonoxynol-9 phosphate, nonoxynol-10, polyoxyethylene nonylphenyl ether phosphate, water

Questions or comments?

1800 760-3236 (Monday - Friday 8:30 AM - 5:00 PM EST)

APLICARE

POVIDONE-IODINE SCRUB

ANTISEPTIC

Povidone iodine scrub

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52380-1855
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
NONOXYNOL-10 (UNII: K7O76887AP)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52380-1855-259 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
2NDC: 52380-1855-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
3NDC: 52380-1855-8240 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
4NDC: 52380-1855-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
5NDC: 52380-1855-3473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/20/2018
6NDC: 52380-1855-7946 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
7NDC: 52380-1855-93800 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
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
Aplicare Products, LLC.081068252manufacture(52380-1855)

Revised: 2/2018
 
Aplicare Products, LLC.


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