MEDLINE- povidone-iodine swab

Medline by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Uses

• antiseptic skin preparation
• help reduce bacteria that potentially can 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

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid excessive heat.

Protect from freezing, avoid excessive heat.

Temperature limits: 15˚C-30˚C.

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

Directions

Swab locally as needed.

Other information

• 1% titratable iodine
• not made with natural rubber latex
• for hospital or professional use only
• store product upright

Inactive ingredients

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

Manufacturing Information

Made in USA by: Medline Industries, LP

Three Lakes Drive,
Northfield, IL 60093 USA.

REF: MDS1982

1-800-MEDLINE V2 RB24HND

www.medline.com

Label

INGREDIENTS AND APPEARANCE

MEDLINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-120
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
NONOXYNOL-10 (UNII: K7O76887AP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-120-09	1 in 1 POUCH	07/01/2024
1		10 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 53329-120-26	4 in 1 BOX	07/01/2024
2		1 in 1 POUCH
2		10 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 53329-120-05	250 in 1 CASE	07/01/2024
3		1 in 1 POUCH
3		10 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/01/2024

Labeler - Medline Industries, LP (025460908)