APLICARE POVIDONE-IODINE- povidone-iodine solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Available from:
Aplicare Products LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic • antiseptic skin preparation • single use when used for patient preoperative skin preparation and/or preinjection indications
Authorization status:
OTC monograph not final
Authorization number:
52380-2801-8

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 Povidone Iodine Solution

Povidone-iodine 10%

Antiseptic

Warnings

Do not use if allergic to iodine

For external use only

Do not use in the eyes

Ask a doctor before use if injuries are

deep or puncture wounds

serious burns

Stop use and ask a doctor if

infection occurs redness

redness, irritation, swelling or pain persists or increases

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

antiseptic skin preparation

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

Keep out of the 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

1% titratable iodine

latex free

for hospital 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)

APLICARE

POVIDONE-IODINE SOLUTION

ANTISEPTIC

NON-STERILE SOLUTION

APLICARE POVIDONE-IODINE

povidone-iodine solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5238 0 -28 0 1

Route of Administration

TOPICAL

Aplicare Products LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5238 0 -28 0 1-8

59 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/19 9 8

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 1/0 1/19 9 8

Labeler -

Aplicare Products LLC (081054904)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Medline Industries, Inc.

0 79 8 0 0 0 21

ma nufa c ture (5238 0 -28 0 1)

Revised: 3/2019

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