povidone-iodine prep pad

povidone-iodine prep pad
SPL v5
SPL
SPL Set ID 06c8a6f6-2fc8-4292-a3b5-6311a918a521
Route
topical
Published
Effective Date 2016-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (10 g)
Inactive Ingredients
water glycerin citric acid monohydrate sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-08-05

Purpose

First Aid Antiseptic

Description

Povidone-Iodine USP 10% (equivalent to 1% titratable iodine)


Medication Information

Warnings

For external use only. Do not apply to persons allergic to Iodine Allergy Alert:

Purpose

First Aid Antiseptic

Directions

• 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 Information

• store at 15°-30°C (59°-86°F)

Inactive Ingredients

(purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide

Description

Povidone-Iodine USP 10% (equivalent to 1% titratable iodine)

Use

•first aid to help prevent skin infection in minor cuts, scrapes, and burns

Do Not Use

• in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor

Active Ingredient

Povidone-Iodine USP 10% (equivalent to 1% titratable iodine)

Package Labeling:

Packet Labeling:

Box Labeling:

Carton Labeling:

Stop Use and Consult A Doctor

if the condition persists or gets worse

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have

• deep or puncture wounds • animal bites • serious burns


Structured Label Content

Warnings

For external use only. Do not apply to persons allergic to Iodine Allergy Alert:

Purpose

First Aid Antiseptic

Directions

• 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 Information (Other information)

• store at 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

(purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide

Use

•first aid to help prevent skin infection in minor cuts, scrapes, and burns

Do Not Use (Do not use)

• in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor

Active Ingredient (Active ingredient)

Povidone-Iodine USP 10% (equivalent to 1% titratable iodine)

Package Labeling:

Packet Labeling:

Box Labeling:

Carton Labeling:

Stop Use and Consult A Doctor (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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• deep or puncture wounds • animal bites • serious burns


Advanced Ingredient Data


Raw Label Data

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