85056-002

85056-002
SPL v1
SPL
SPL Set ID 2e617119-531d-af7b-e063-6294a90a8ca6
Route
CUTANEOUS
Published
Effective Date 2025-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (40 g)
Inactive Ingredients
Petrolatum Antioxidant 119 Paraffin Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-18

Description

Salicylic acid 40%

Purpose

corn and callus remover


Medication Information

Purpose

corn and callus remover

Description

Salicylic acid 40%

Use

Uses:for softening and removing corns and calluses

Section 50565-1

Keep out of reach of children if swallowed ,get medical help or contact a Poison Control

Center immediately.

Section 50566-9

Stop use and ask a doctor if you have poor blood circulation, are diabetic,pregnant or

breastfeeding.

Section 50567-7

When using this product:keep out of eyes, ears and mouth. In case of contact with eyes, rinse

eyes thoroughly with water.

Section 51945-4

Warnings

For external use only.

Directions

1.May soak corn/callus in warm water for 5 minutes to assist in removal before apply the patch.

2.Clean and dry affected area thoroughly, then apply the patch directly to the corn/callus,

ensuring the medication core does not touch surrounding healthy skin. If corn/callus is small

than medicatied core,remove and trim the core to fit precisely before apply. For extra protection,

apply a thin layer of Vaseline or a similar protective cream around the corn/callus.

3. Secure the patch in place using additional bandage ifnecessary to prevent any movement during wear.

4.Replace the patch with a fresh one every 12 to 24 hours as needed, adhering to the recommended time frame for optimal efficacy.

5.Continue this application regimen until the corn/callus is fully resolved,repeating steps 1 through 4 as necessary.

Do Not Use

Do not use if you have allergies to Salicylic acid or latex. Avoid using on healthy skin,open

wounds, infected or inflamed areas.

Other Information

store between 58°F to 85°F

Active Ingredient(s)

Salicylic acid 40%

Inactive Ingredients

Vaseline, Antioxidant, Hard paraffin, Titanium dioxide


Structured Label Content

Use

Uses:for softening and removing corns and calluses

Section 50565-1 (50565-1)

Keep out of reach of children if swallowed ,get medical help or contact a Poison Control

Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you have poor blood circulation, are diabetic,pregnant or

breastfeeding.

Section 50567-7 (50567-7)

When using this product:keep out of eyes, ears and mouth. In case of contact with eyes, rinse

eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

corn and callus remover

Warnings

For external use only.

Directions

1.May soak corn/callus in warm water for 5 minutes to assist in removal before apply the patch.

2.Clean and dry affected area thoroughly, then apply the patch directly to the corn/callus,

ensuring the medication core does not touch surrounding healthy skin. If corn/callus is small

than medicatied core,remove and trim the core to fit precisely before apply. For extra protection,

apply a thin layer of Vaseline or a similar protective cream around the corn/callus.

3. Secure the patch in place using additional bandage ifnecessary to prevent any movement during wear.

4.Replace the patch with a fresh one every 12 to 24 hours as needed, adhering to the recommended time frame for optimal efficacy.

5.Continue this application regimen until the corn/callus is fully resolved,repeating steps 1 through 4 as necessary.

Do Not Use (Do not use)

Do not use if you have allergies to Salicylic acid or latex. Avoid using on healthy skin,open

wounds, infected or inflamed areas.

Other Information (Other information)

store between 58°F to 85°F

Active Ingredient(s)

Salicylic acid 40%

Inactive Ingredients (Inactive ingredients)

Vaseline, Antioxidant, Hard paraffin, Titanium dioxide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)