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

APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1855
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1855-2	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
2	NDC: 52380-1855-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
3	NDC: 52380-1855-8	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
4	NDC: 52380-1855-6	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
5	NDC: 52380-1855-3	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/20/2018
6	NDC: 52380-1855-7	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
7	NDC: 52380-1855-9	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/1998

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081068252	manufacture(52380-1855)

Revised: 2/2018

Document Id: 65a8860a-35f7-7650-e053-2a91aa0a2e8e

34390-5

Set id: aea2c0fe-f25f-424f-827a-8fe30ad3bee0

Version: 7

Effective Time: 20180220

 

Aplicare Products, LLC.