MEDLINE NASAL ANTISEPTIC SWABS- povidone iodine swabstick solution

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

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Active ingredient:
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Available from:
Medline Industries, Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - antiseptic skin preparation - helps reduce bacteria that can potentially cause skin infections
Authorization status:
OTC monograph not final
Authorization number:
53329-497-26, 53329-497-42, 53329-497-66

MEDLINE NASAL ANTISEPTIC SWABS- povidone iodine swabstick solution

Medline Industries, Inc

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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Medline Nasal Antiseptic Swabs

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpos e

Antiseptic

Us es

antiseptic skin preparation

helps reduce bacteria that can potentially cause skin infections

Warnings

For external use only

Do not use

if allergic to iodine

in the eyes

on children less than 3 years old

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

infection occurs

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult

a poison control center immediately.

Avoid excessive heat. Store at room temperature.

Directions

NASAL APPLICATION:

Use a tissue to clean the inside of both

nostrils, including the inside tip of nostril.

Discard.

Insert swab comfortably into one nostril

and rotate for 30 seconds, covering all

surfaces. Discard swabstick.

Using a 2nd swab, repeat step 2 with the

other nostril.

Repeat the application in both nostrils,

using the 3rd and 4th swabs.

Do not blow nose. If solution drips, gently

wipe with a tissue.

Other information

1% titratable iodine

not made with natural rubber latex

for hospital or professional use only

Inactive ingredients

disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

PRINCIPAL DISPLAY PANEL - Swabstick Packet

NDC 53329-497-26

Medline

Antiseptic Nasal Swabs

Povidone-Iodine USP 10%

Non-sterile, Single Use Only

This product is not made with natural rubber latex

1 4-inch saturated swabstick LEFT NOSTRIL

1 4-inch saturated swabstick RIGHT NOSTRIL

Made in the USA by Medline, Industries, Inc. Northfield, IL 60093 USA

REF MDS1982

Protect from Freezing

Avoid Excessive Heat

Temperature Limits: 15°C - 30 °C

MEDLINE NASAL ANTISEPTIC SWABS

povidone iodine swabstick solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53329 -49 7

Medline Industries, Inc

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, ANHYDRO US (UNII: 22ADO53M6 F)

HYDRO XYETHYL CELLULO SE ( 2 0 0 0 MPA.S 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:53329 -49 7-42

2 in 1 BOX

0 1/15/20 18

1

NDC:53329 -49 7-26

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

2

NDC:53329 -49 7-6 6

250 in 1 CASE

0 1/15/20 18

2

NDC:53329 -49 7-26

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

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 1/15/20 18

Labeler -

Medline Industries, Inc (025460908)

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 (53329 -49 7)

Revised: 3/2019

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