MEDLINE NASAL ANTISEPTIC SWABS- povidone iodine swabstick solution

Medline Nasal Antiseptic Swabs by

Drug Labeling and Warnings

Medline Nasal Antiseptic Swabs by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Uses

• 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:

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

INGREDIENTS AND APPEARANCE

MEDLINE NASAL ANTISEPTIC SWABS 
povidone iodine swabstick solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-497
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-497-42	2 in 1 BOX	01/15/2018
1	NDC: 53329-497-26	10 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 53329-497-66	250 in 1 CASE	01/15/2018
2	NDC: 53329-497-26	10 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2018

Labeler - Medline Industries, Inc (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products LLC		081054904	manufacture(53329-497)