Povidone Iodine Gel Swabstick

Povidone Iodine Gel Swabstick
SPL v1
SPL
SPL Set ID 1058b4ff-c337-7a5a-e063-6394a90aca41
Route
TOPICAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Glycerin Hydroxyethyl Cellulose (4000 Mpa.s At 1%) Sodium Phosphate, Dibasic, Anhydrous Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Povidone-Iodine 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine 10%

Label

NDC 68786-418-01

Use(s)

• For preparation of the skin prior to surgery

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

• For venipuncture skin preparation

Warnings

For External Use Only

Directions

• Tear at notch • Remove applicator • Use only once

As a first aid antiseptic:

• Clean affected area

• Apply 1 to 3 times daily

• May be covered with a sterile bandage

• If bandaged, let dry first

For preoperative patient skin preparation:

• Clean area

• Apply to operative site prior to surgery

For Venipuncture skin preparation:

• Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds.

• After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter.

• Allow site to dry for approximately 30 seconds.

• If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.

Do Not Use

• In the eyes or over large areas of the body

• Longer than 1 week unless directed by a doctor

Active Ingredient

Povidone-Iodine 10%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

Inactive Ingredients

Demineralized Water, Disodium Phosphate Anhydrous, Glycerin, Natrozole HHR

Questions and Comments?

1-888-369-2739 M-F, 9-5 EST

Stop Use and Ask A Doctor If

Condition persists or gets worse

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Ask A Doctor Before Use If You Have

• Deep or puncture wounds

• Animal bites

• Serious burns


Structured Label Content

Label

NDC 68786-418-01

Use(s)

• For preparation of the skin prior to surgery

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

• For venipuncture skin preparation

Purpose

Antiseptic

Warnings

For External Use Only

Directions

• Tear at notch • Remove applicator • Use only once

As a first aid antiseptic:

• Clean affected area

• Apply 1 to 3 times daily

• May be covered with a sterile bandage

• If bandaged, let dry first

For preoperative patient skin preparation:

• Clean area

• Apply to operative site prior to surgery

For Venipuncture skin preparation:

• Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds.

• After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter.

• Allow site to dry for approximately 30 seconds.

• If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.

Do Not Use (Do not use)

• In the eyes or over large areas of the body

• Longer than 1 week unless directed by a doctor

Active Ingredient

Povidone-Iodine 10%

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

Inactive Ingredients

Demineralized Water, Disodium Phosphate Anhydrous, Glycerin, Natrozole HHR

Questions and Comments?

1-888-369-2739 M-F, 9-5 EST

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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 (800-222-1222) 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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