Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID ff52ba65-268b-46ce-8008-148955bb2720
Routes
TOPICAL TRANSDERMAL
Published
Effective Date 2019-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2004-04-26

Description

Active Ingredient Salicylic acid 40%


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert: This product contains natural rubber latex which may cause allergic reactions

Indications and Usage

Uses

For the removal of corns and calluses

Relieves pain by removing corns and calluses

Dosage and Administration

Directions

wash affected area and dry thoroughly

apply medicated plaster over corn or callus

after 48 hours remove the medicated plaster

repeat this procedure every 48 hours as needed for up to 14 days (until corn/callus is removed)

Description

Active Ingredient Salicylic acid 40%

Section 44425-7

Other Information

store at 15° to 30° C (59° to 86° F), away from heat

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor or podiatrist if

discomfort persists

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

Section 50570-1

Do not use

on irritated skin

on any area that is infected or reddened

if you are a diabetic

if you have poor blood circulation

Section 51727-6

Inactive Ingredients

Lanolin, paraffin, petrolatum, phenol, and zinc oxide, mounted in a natural rubber latex ring on adhesive fabric with a polyethylene film cover.

Section 51945-4

Yat Tip Tor

Corn & Callus Remover

NDC 61822-0047-1

10 Plasters

Section 53413-1

Questions or Comments? (888) 221-3496 M-F 9am to 5p

Section 55105-1

Purpose

Corn and callus remover

Section 55106-9

Active Ingredient

Salicylic acid 40%


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

wash affected area and dry thoroughly

apply medicated plaster over corn or callus

after 48 hours remove the medicated plaster

repeat this procedure every 48 hours as needed for up to 14 days (until corn/callus is removed)

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert: This product contains natural rubber latex which may cause allergic reactions

Section 44425-7 (44425-7)

Other Information

store at 15° to 30° C (59° to 86° F), away from heat

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor or podiatrist if

discomfort persists

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

Section 50570-1 (50570-1)

Do not use

on irritated skin

on any area that is infected or reddened

if you are a diabetic

if you have poor blood circulation

Section 51727-6 (51727-6)

Inactive Ingredients

Lanolin, paraffin, petrolatum, phenol, and zinc oxide, mounted in a natural rubber latex ring on adhesive fabric with a polyethylene film cover.

Section 51945-4 (51945-4)

Yat Tip Tor

Corn & Callus Remover

NDC 61822-0047-1

10 Plasters

Section 53413-1 (53413-1)

Questions or Comments? (888) 221-3496 M-F 9am to 5p

Section 55105-1 (55105-1)

Purpose

Corn and callus remover

Section 55106-9 (55106-9)

Active Ingredient

Salicylic acid 40%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)