SWAB- povidone-iodine swab

Swab by

Drug Labeling and Warnings

Swab by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical Inc., Jiangsu Province Jianerkang Medical Dressing Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

INDICATIONS & USAGE

Health-care antiseptic for preparation of the skin prior to surgery.

First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns.

WARNINGS

For external use only.

Do not use or apply in the eyes on individuals who are allergic or sensitive to iodine over large areas of the body as a first aid antiseptic longer than 1 week unless directed by a doctor

Discontinue use if irritation and redness develop

Consult a doctor in case of deep or puncture wounds animal bites serious burns

Stop use and consult a doctor if the condition persists or gets worse

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

For preparation of the skin prior to surgery clean the affected area remove swab by stick apply to the operative site prior to surgery

For use as a first aid antiseptic clean the affected area apply a small amount of this product on the area 1 - 3 times daily May be covered with a sterile bandage If bandaged, let dry first

OTHER SAFETY INFORMATION

Store at 59-86ºF (15-30ºC).

INACTIVE INGREDIENT

Citric Acid, Sodium Hydroxide, Nonoxynol-10, Glycerin, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SWAB 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-8630
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-8630-3	10 in 1 CASE	01/17/2017
1	NDC: 68599-8630-2	50 in 1 BOX
1	NDC: 68599-8630-1	1 in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 68599-8630-6	10 in 1 CASE	01/17/2017
2	NDC: 68599-8630-5	25 in 1 BOX
2	NDC: 68599-8630-4	3 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/17/2017

Labeler - McKesson Medical-Surgical Inc. (023904428)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Province Jianerkang Medical Dressing Co.,Ltd		530968767	manufacture(68599-8630)