APLICARE POVIDONE IODINE SWABSTICK- 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.
INN (International Name):
POVIDONE-IODINE
Composition:
IODINE 10 mg in 1 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Antiseptic skin preparation
Authorization status:
OTC monograph not final
Authorization number:
52380-0038-7

APLICARE POVIDONE IODINE SWABSTICK- 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 Swabstick

Povidone-iodine 10%

Antiseptic

Antiseptic skin preparation

For external use only

Do not use

if allergic to iodine

in the eyes

Avoid excessive heat. Store between 15-30ºC(59-86ºF).

A sk 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

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

1% titratable iodine

not made with natural rubber latex

for hospital or professional use only

Inactive ingredients

disodium phosphate

glycerin

hydroxy ethylcellulose

nonoxynol-10

simethicone

water

For questions or comments

800-633-5463

APLICARE POVIDONE IODINE SWABSTICK

povidone iodine solution

Aplicare Products, LLC.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5238 0 -0 0 38

Route of Administration

TOPICAL

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

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

HYDRO XYETHYL CELLULO SE ( 2 0 0 0 CPS AT 1%) (UNII: S38 J6 RZN16 )

NO NO XYNO L-10 (UNII: K7O76 8 8 7AP)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5238 0 -0 0 38 -7

2 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 6 /0 1/20 0 3

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 6 /0 1/20 0 3

Labeler -

Aplicare Products, LLC. (081054904)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Aplicare Pro ducts, LLC.

0 8 10 549 0 4

ma nufa c ture (5238 0 -0 0 38 )

Revised: 12/2019

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