SPL v1
SPL
SPL Set ID 8b71018c-766f-43fb-b191-a9650e6c3544
Route
TOPICAL
Published
Effective Date 2013-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 g)
Inactive Ingredients
D&c Yellow No. 11 Methylparaben Methyl Salicylate Propylparaben Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-02-21

Description

Active ingredient Salicylic acid 17%


Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

Uses

for the removal of corns and calluses; relieves pain by removing corns and calluses.

Dosage and Administration

Directions

Apply a thin coat of the medication to cover the entire wart, callus, or corn using the applicator if provided. Be careful to apply it only to the affected area and not the surrounding skin. Let dry for 5 minutes. Repeat this procedure 1 to 2 times daily for up to 2 weeks for corns and calluses and 12 weeks for warts or as directed by your doctor.

Description

Active ingredient Salicylic acid 17%

Section 50565-1

Keep out of reach of children.

Section 50570-1

Tamper Evident

Do not use if seal is broken or missing.

Section 51727-6

Inactive ingredients

D&C yellow #11, methylparaben, methyl salicylate, propylparaben, white petrolatum

Section 51945-4

Section 55105-1

Purpose

Corn and callus remover

Section 55106-9

Active ingredient

Salicylic acid 17%


Structured Label Content

Indications and Usage (34067-9)

Uses

for the removal of corns and calluses; relieves pain by removing corns and calluses.

Dosage and Administration (34068-7)

Directions

Apply a thin coat of the medication to cover the entire wart, callus, or corn using the applicator if provided. Be careful to apply it only to the affected area and not the surrounding skin. Let dry for 5 minutes. Repeat this procedure 1 to 2 times daily for up to 2 weeks for corns and calluses and 12 weeks for warts or as directed by your doctor.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50570-1 (50570-1)

Tamper Evident

Do not use if seal is broken or missing.

Section 51727-6 (51727-6)

Inactive ingredients

D&C yellow #11, methylparaben, methyl salicylate, propylparaben, white petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Corn and callus remover

Section 55106-9 (55106-9)

Active ingredient

Salicylic acid 17%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)