SPL v2
SPL
SPL Set ID 270009d2-d87e-5964-e063-6394a90af526
Route
CUTANEOUS
Published
Effective Date 2024-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (100 mg)
Inactive Ingredients
Dimethicone Glyceryl 1-stearate Sophora Flavescens Root Sauromatum Giganteum Root Water Lonicera Japonica Top Podofilox Cetyl Alcohol Phellodendron Amurense Bark Lithospermum Erythrorhizon Root Isatis Tinctoria Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-16

Description

Salicylic acid 5% w/w


Medication Information

Warnings and Precautions



Warnings

For exteral use only. Flammable.Keep away fromfire and flame.Do not use on irritated skin or onany area that is infected or reddened .on the faceor mucous membranes .Not recommended forindividuals with diabetes or poor blood circulation.

Indications and Usage



Directions

.Clean and dry the affected area thoroughly.Apply a small amount of the wart removalcream directly to the wart,avoiding contactwith surrounding healthy skin.

Dosage and Administration



Uses

Take an appropriate amount.

. For the removal of common and plantarwarts. the common wart is easily recognized bythe rough"cauliflower-like"appearance on thesurface.

The plantar wart is recognized by its locationonly on the bottom of the foot, its tendernessand interruption of the footprint pattern.

Description

Salicylic acid 5% w/w

Section 50565-1

Keep out of reach of children.Children should use this product under adultsupervision.

Section 50566-9

Stop use and ask a doctor if discomfort persists.

Section 50567-7

When using this productavoid contact with eyes. lf product getsintothe eye,flush with water for 15minutes,·avoid inhaling vapors . cap tightly and store atroomtemperature away from heat.

Section 50570-1



Ask a doctor before use if you are

Pregnant

breastfeeding

Children should use this product under adult

supervision.

Section 51727-6

Water

Cetyl Alcohol

Dimethicone

Glyceryl 1-stearate

Podophyllotoxin

LITHOSPERMUM ERYTHRORHIZON ROOT

LONICERA JAPONICA TOP

PHELLODENDRON AMURENSE BARK

SOPHORA FLAVESCENS ROOT

ISATIS TINCTORIA ROOT

SAUROMATUM GIGANTEUM ROOT

Section 51945-4

Section 55105-1



Quick and EffectiveWart RemovalSolution this is wartremover offers a

powerful formula forquick elimination,with easy, mess-freeapplication forat-home use. lt'sskin-friendly,minimizes irritation,and delivers visibleimprovements forcomplete wartremoval withconsistent use.

Section 55106-9

Salicylic acid 5% w/w


Structured Label Content

Indications and Usage (34067-9)



Directions

.Clean and dry the affected area thoroughly.Apply a small amount of the wart removalcream directly to the wart,avoiding contactwith surrounding healthy skin.

Dosage and Administration (34068-7)



Uses

Take an appropriate amount.

. For the removal of common and plantarwarts. the common wart is easily recognized bythe rough"cauliflower-like"appearance on thesurface.

The plantar wart is recognized by its locationonly on the bottom of the foot, its tendernessand interruption of the footprint pattern.

Warnings and Precautions (34071-1)



Warnings

For exteral use only. Flammable.Keep away fromfire and flame.Do not use on irritated skin or onany area that is infected or reddened .on the faceor mucous membranes .Not recommended forindividuals with diabetes or poor blood circulation.

Section 50565-1 (50565-1)

Keep out of reach of children.Children should use this product under adultsupervision.

Section 50566-9 (50566-9)

Stop use and ask a doctor if discomfort persists.

Section 50567-7 (50567-7)

When using this productavoid contact with eyes. lf product getsintothe eye,flush with water for 15minutes,·avoid inhaling vapors . cap tightly and store atroomtemperature away from heat.

Section 50570-1 (50570-1)



Ask a doctor before use if you are

Pregnant

breastfeeding

Children should use this product under adult

supervision.

Section 51727-6 (51727-6)

Water

Cetyl Alcohol

Dimethicone

Glyceryl 1-stearate

Podophyllotoxin

LITHOSPERMUM ERYTHRORHIZON ROOT

LONICERA JAPONICA TOP

PHELLODENDRON AMURENSE BARK

SOPHORA FLAVESCENS ROOT

ISATIS TINCTORIA ROOT

SAUROMATUM GIGANTEUM ROOT

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Quick and EffectiveWart RemovalSolution this is wartremover offers a

powerful formula forquick elimination,with easy, mess-freeapplication forat-home use. lt'sskin-friendly,minimizes irritation,and delivers visibleimprovements forcomplete wartremoval withconsistent use.

Section 55106-9 (55106-9)

Salicylic acid 5% w/w


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)