83781-003 Updete V2

83781-003 Updete V2
SPL v2
SPL
SPL Set ID 09777a9d-2dd1-4f87-e063-6294a90ac139
Route
TOPICAL
Published
Effective Date 2023-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (40 g)
Inactive Ingredients
Paraffin Phenol Lanolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-05

Description

Salicylic acid 40%

Purpose

Corn and callus remover


Medication Information

Purpose

Corn and callus remover

Description

Salicylic acid 40%

Use

for the removal of corns from foot and hand.

Stop Use

discomfort persists.

Warnings

for external use only

Questions
Ask Doctor

discomfort persists.

Directions

■Wash affected corn and dry thoroughly.

■Please cut the medicated patch as a suitable size to cover your corn.

■Place frmly the medicated round part over the center of corn. Adhesive next to skin.

■Repeart the treatment as need until corn is removed. (The result may vary from person.)

■May soak corn in warm water for 5 minutes to assist in the removal.

Do Not Use

on irritated skin or any area that is infected or reddened.

When Using

if product gets in eyes,flush with water for 15 minutes.

Ask a doctor before use if you have

■diabetes

■poor blood circulation

■under 14 years old

■pregnant and lactating women

Active Ingredient

Salicylic acid 40%

Other Information

store between 20°to 25℃ (68°to 77℉)

Inactive Ingredients

hard paraffin, lanolin, phenol

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

for the removal of corns from foot and hand.

Purpose

Corn and callus remover

Stop Use

discomfort persists.

Warnings

for external use only

Questions
Ask Doctor

discomfort persists.

Directions

■Wash affected corn and dry thoroughly.

■Please cut the medicated patch as a suitable size to cover your corn.

■Place frmly the medicated round part over the center of corn. Adhesive next to skin.

■Repeart the treatment as need until corn is removed. (The result may vary from person.)

■May soak corn in warm water for 5 minutes to assist in the removal.

Do Not Use (Do not use)

on irritated skin or any area that is infected or reddened.

When Using

if product gets in eyes,flush with water for 15 minutes.

Ask a doctor before use if you have

■diabetes

■poor blood circulation

■under 14 years old

■pregnant and lactating women

Active Ingredient

Salicylic acid 40%

Other Information (Other information)

store between 20°to 25℃ (68°to 77℉)

Inactive Ingredients (Inactive ingredients)

hard paraffin, lanolin, phenol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.


Advanced Ingredient Data


Raw Label Data

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