83818-009

83818-009
SPL v1
SPL
SPL Set ID 29e83a7d-a9c6-5aff-e063-6394a90a843a
Route
topical
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (40 g)
Inactive Ingredients
phenol paraffin lanolin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-12-23

Purpose

Wart, Corn and Small Callus Remover

Description

Salicylic acid 40 %


Medication Information

Warnings

For external use only.

Purpose

Wart, Corn and Small Callus Remover

Directions

1.Wash the affected area with soap and warm water. Rinse thoroughly and drycompletely.

2. Select the appropriate size pad (large or small) that fits the wart, corn, orsmall callus.

3. Apply the medicated center directly over the wart, corn, or small callus.

Avoid covering healthy skin.4. Use the provided PU adhesive bandage to secure the pad in place, ensuring

it stays firmly attached.5. Leave the pad in place for 24 hours. After 24 hours, remove the pad andclean the affected area.

6. Repeat the application process daily as needed until the wart, corn, or callusis removed.

7. Do not use it for more than 12 weeks unless directed by a doctor.

Other Information

store between 59° and 86°F (15°C and 30°C)

Inactive Ingredients

Hard paraffin, lanolin, phenol

Description

Salicylic acid 40 %

Principal Display Panel

Use

For the removal of common warts, plantar warts, corns, and small calluses.

Stop Use

Redness, irritation, swelling, or pain persists or worsens.The wart, corn, or callus does not improve within the expected treatmentperiod (up to 12 weeks).

Questions

Call 1-914-875-2018

Ask Doctor

Redness, irritation, swelling, or pain persists or worsens.The wart, corn, or callus does not improve within the expected treatmentperiod (up to 12 weeks).

Do Not Use

On open wounds, irritated or infected skin,skin tags, moles, facial warts, genital warts,Molluscum, or milia (white bumps), or mucous membranes,

When Using

Avoid contact with eyes or healthy skin. In case of accidental contact, rinse thoroughly with water.

Active Ingredient

Salicylic acid 40 %

Keep Oot of Reach of Children

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


Structured Label Content

Warnings

For external use only.

Purpose

Wart, Corn and Small Callus Remover

Directions

1.Wash the affected area with soap and warm water. Rinse thoroughly and drycompletely.

2. Select the appropriate size pad (large or small) that fits the wart, corn, orsmall callus.

3. Apply the medicated center directly over the wart, corn, or small callus.

Avoid covering healthy skin.4. Use the provided PU adhesive bandage to secure the pad in place, ensuring

it stays firmly attached.5. Leave the pad in place for 24 hours. After 24 hours, remove the pad andclean the affected area.

6. Repeat the application process daily as needed until the wart, corn, or callusis removed.

7. Do not use it for more than 12 weeks unless directed by a doctor.

Other Information (Other information)

store between 59° and 86°F (15°C and 30°C)

Inactive Ingredients (Inactive ingredients)

Hard paraffin, lanolin, phenol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

For the removal of common warts, plantar warts, corns, and small calluses.

Stop Use

Redness, irritation, swelling, or pain persists or worsens.The wart, corn, or callus does not improve within the expected treatmentperiod (up to 12 weeks).

Questions

Call 1-914-875-2018

Ask Doctor

Redness, irritation, swelling, or pain persists or worsens.The wart, corn, or callus does not improve within the expected treatmentperiod (up to 12 weeks).

Do Not Use (Do not use)

On open wounds, irritated or infected skin,skin tags, moles, facial warts, genital warts,Molluscum, or milia (white bumps), or mucous membranes,

When Using

Avoid contact with eyes or healthy skin. In case of accidental contact, rinse thoroughly with water.

Active Ingredient

Salicylic acid 40 %

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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