POVIDONE-IODINE SWABSTICKS SINGLES- povidone-iodine swab
POVIDONE-IODINE SWABSTICKS TRIPLES- povidone-iodine swab
Medline Industries, LP

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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945/;946 Medline PVP Swabs

Active ingredient

Povidone-Iodine, 10.0% w/v

Purpose

Antiseptic

Uses

for preparation of the skin prior to surgery
first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use

in the eyes
longer than one week unless directed by a doctor
on individuals who are allergic or sensitive to iodine
or apply over large areas of the body

Stop use and ask a doctor

irritation and redness develop
condition persists for more than 72 hours
In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area.
For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other information

protect from freezing., avoid excessive heat

Inactive ingredients

citric acid, disodium phosphate, purified water

Manufacturing Information

Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in China
www.medline.com
1-800-MEDLINE (633-5463)
REF: MDS093901
V1 RF22LPD

Package Label

Label V1 RF22LPD

Tiple Swab Package Label

label 3

POVIDONE-IODINE SWABSTICKS SINGLES
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-945
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-945-29	50 in 1 BOX	12/12/2018
1		1 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:53329-945-09	1 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2007

POVIDONE-IODINE SWABSTICKS TRIPLES
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-946
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-946-75	25 in 1 BOX	12/12/2018
1	NDC:53329-946-02	3 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:53329-946-02	3 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2007

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)