drug facts

drug facts
SPL v3
SPL
SPL Set ID cb5c846e-0234-4ffa-8c12-40ea78ccaf1e
Route
topical
Published
Effective Date 2009-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (0.1 mL)

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2008-01-01

Description

Cat.40000-040      NDC 34645-4000-2     Qty. 1ea Povidone-Iodine Swab Stick Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine For External Use Only Distributed by: Cardinal Health Dublin, OH 43017 USA Made in China


Medication Information

Warnings and Precautions

Warnings

For external use only.

Active Ingredient

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Indications and Usage


Directions



Clean the affected area



Apply product on the area 1-3 times daily and discard



May be covered with a sterile bandage when dry

Description

Cat.40000-040      NDC 34645-4000-2     Qty. 1ea Povidone-Iodine Swab Stick Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine For External Use Only Distributed by: Cardinal Health Dublin, OH 43017 USA Made in China

Section 44425-7


Other information



Store at room temperature: 15o - 30o C (59o-86o F)

Section 50565-1


Keep out of reach of children.



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

Section 50566-9


Discontinue use



If irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.

Section 50567-7

Uses

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.

Section 50569-3


Consult a doctor in case of



* deep or puncture wounds * animal bites * serious burns.
Section 50570-1

Do not * use in the eyes * use on individuals who are allergic or sensitive to iodine

* apply over large areas of the body * use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Section 51727-6

Inactive ingredients

aitric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

Section 51945-4

Cat.40000-040      NDC 34645-4000-2     Qty. 1ea

Povidone-Iodine Swab Stick

Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat

Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine

For External Use Only

Distributed by:

Cardinal Health

Dublin, OH 43017 USA

Made in China

Section 55105-1

Purpose

Antiseptic


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Indications and Usage (34067-9)


Directions



Clean the affected area



Apply product on the area 1-3 times daily and discard



May be covered with a sterile bandage when dry

Section 44425-7 (44425-7)


Other information



Store at room temperature: 15o - 30o C (59o-86o F)

Section 50565-1 (50565-1)


Keep out of reach of children.



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

Section 50566-9 (50566-9)


Discontinue use



If irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.

Section 50567-7 (50567-7)

Uses

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.

Section 50569-3 (50569-3)


Consult a doctor in case of



* deep or puncture wounds * animal bites * serious burns.
Section 50570-1 (50570-1)

Do not * use in the eyes * use on individuals who are allergic or sensitive to iodine

* apply over large areas of the body * use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

aitric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

Section 51945-4 (51945-4)

Cat.40000-040      NDC 34645-4000-2     Qty. 1ea

Povidone-Iodine Swab Stick

Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat

Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine

For External Use Only

Distributed by:

Cardinal Health

Dublin, OH 43017 USA

Made in China

Section 55105-1 (55105-1)

Purpose

Antiseptic


Advanced Ingredient Data


Raw Label Data

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