SPL v2
SPL
SPL Set ID 470ddab0-a98a-fba1-e063-6394a90a63d3
Route
TOPICAL
Published
Effective Date 2025-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 g)
Inactive Ingredients
Sodium Bicarbonate Polysorbate 80 Potassium Iodide Polyethylene Glycol 400 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-28

Description

Povidone-lodine 10%w/w


Medication Information

Warnings and Precautions

For external use only.

Do not apply to persons allergic to iodine.

Indications and Usage

Directions

Clean area. Apply to the operative site prior to surgery.

Dosage and Administration

Apply topically as needed to cleanse intendend area;

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Description

Use for preparation of the skin prior to surgery.

Sterile in unopened, undamaged package.

Not made with natural rubber latex.

Section 50565-1

Keep out of reach of children

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

Section 50570-1

Do not Use in the eyes.

Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

Section 51727-6

Sodium bicarbonate, polysorbate-80, polyethylene glycol, potassium iodide, purified water

Section 51945-4

Section 55105-1

Antiseptic

For preparation of the skin prior to surgery

Section 55106-9

Povidone-lodine 10%w/w

Section 60561-8

1% titratable iodine.

Store at ambient temperature.


Structured Label Content

Indications and Usage (34067-9)

Directions

Clean area. Apply to the operative site prior to surgery.

Dosage and Administration (34068-7)

Apply topically as needed to cleanse intendend area;

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Warnings and Precautions (34071-1)

For external use only.

Do not apply to persons allergic to iodine.

Description (34089-3)

Use for preparation of the skin prior to surgery.

Sterile in unopened, undamaged package.

Not made with natural rubber latex.

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50570-1 (50570-1)

Do not Use in the eyes.

Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

Section 51727-6 (51727-6)

Sodium bicarbonate, polysorbate-80, polyethylene glycol, potassium iodide, purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

For preparation of the skin prior to surgery

Section 55106-9 (55106-9)

Povidone-lodine 10%w/w

Section 60561-8 (60561-8)

1% titratable iodine.

Store at ambient temperature.


Advanced Ingredient Data


Raw Label Data

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