SPL v4
SPL
SPL Set ID 1d443682-ebfa-2eac-e063-6294a90a9fe1
Route
TOPICAL
Published
Effective Date 2024-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 mg)
Inactive Ingredients
Lanolin Paraffin Phenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

salicylic acid 1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

DIRECTIONS

wash affected area:may soak wart in warm water for 5 minutes

dry area thoroughly

remove bandage strips by peeling backing off

if necessary, cut medicated patch to fit wart

carefully apply medicated plaster

repeat procedure every 48 hours as needed(until wart is removed)

for up to 12 week

Dosage and Administration

One patch per day, each patch contains 1 mg of tolnaftate.

Description

salicylic acid 1%

Section 50565-1

keep out of reach of children

If swallowed, get medica help or contact a Poison Control Center right way

Section 50567-7

when using

Ask a doctor before use if you have diabetes poor blood circulatio

Section 50570-1

on irritated, infected or reddened skin

on genital warts and warts on the face

on moles, birthmarks and warts with hair growing form them

on mucous membranes

Section 51727-6

hard paraffin, lanolin, phenol

Section 51945-4

Section 55105-1

Wart Remover

Section 55106-9

salicylic acid 1%

Section 60561-8

Store between 59° and 86'F (15° and 30° C)


Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS

wash affected area:may soak wart in warm water for 5 minutes

dry area thoroughly

remove bandage strips by peeling backing off

if necessary, cut medicated patch to fit wart

carefully apply medicated plaster

repeat procedure every 48 hours as needed(until wart is removed)

for up to 12 week

Dosage and Administration (34068-7)

One patch per day, each patch contains 1 mg of tolnaftate.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

keep out of reach of children

If swallowed, get medica help or contact a Poison Control Center right way

Section 50567-7 (50567-7)

when using

Ask a doctor before use if you have diabetes poor blood circulatio

Section 50570-1 (50570-1)

on irritated, infected or reddened skin

on genital warts and warts on the face

on moles, birthmarks and warts with hair growing form them

on mucous membranes

Section 51727-6 (51727-6)

hard paraffin, lanolin, phenol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Wart Remover

Section 55106-9 (55106-9)

salicylic acid 1%

Section 60561-8 (60561-8)

Store between 59° and 86'F (15° and 30° C)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)