SPL v1
SPL
SPL Set ID 3c414e9b-6c40-2c8d-e063-6394a90af4a6
Route
TOPICAL
Published
Effective Date 2025-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 g)
Inactive Ingredients
Saffron Argan Oil Glycerin Alpha-tocopherol Tea Tree Oil Cupressus Sempervirens Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-13

Description

Salicylic Acid 5% For the removal of common warts.


Medication Information

Warnings and Precautions

Warnings.The labeling of the product contains the following warnings underthe heading “Warnings”

(1)For products containing any ingredient identified in S MO28.10.(i)For external use only.(ii) Do not use this product on irritated skin, on any area that isinfected or reddened, if you are a diabetic, or if you have poorblood circulation.

(iii) lf discomfort persists, see your doctor.(iv) Do not use on moles, birthmarks, warts with hair growing fromthem, genital warts, or warts on the face or mucous membranes.

(2) For any product formulated in a flammable vehicle.(i)The labeling should contain an appropriate flammability signalword, e.g.“extremely flammable",“flammable".“combustible”consistent with 16 CFR 1500.3(b)(10).(ii) Keep away from fire or flame.

Indications and Usage

For the removal of plantar warts on the bottom of the foot. The

plantar wart is recognized by its location only on the bottom of the

foot, its tenderness, and the interruption of the footprint pattern.

Dosage and Administration

(1)For the removal of common warts. The common wart is easily

recognized by the rough 'cauliflower-like’ appearance of the surface.

Description

Salicylic Acid 5% For the removal of common warts.

Section 50565-1

KEEP OUT OF CHILDREN

Section 50570-1

Do not use this product on irritated skin, on any area that is

infected or reddened, if you are a diabetic, or if you have poor

blood circulation.

Section 51727-6

Salicylic acidTea tree oilCepress leaf extractSaffron

GlycerinArgan oilVitamin E

Section 51945-4

Section 55105-1

Fast HealingTransparentWaterproofNon-DryingDrug-Free

Section 55106-9

Salicylic Acid 5%

For the removal of common warts.


Structured Label Content

Indications and Usage (34067-9)

For the removal of plantar warts on the bottom of the foot. The

plantar wart is recognized by its location only on the bottom of the

foot, its tenderness, and the interruption of the footprint pattern.

Dosage and Administration (34068-7)

(1)For the removal of common warts. The common wart is easily

recognized by the rough 'cauliflower-like’ appearance of the surface.

Warnings and Precautions (34071-1)

Warnings.The labeling of the product contains the following warnings underthe heading “Warnings”

(1)For products containing any ingredient identified in S MO28.10.(i)For external use only.(ii) Do not use this product on irritated skin, on any area that isinfected or reddened, if you are a diabetic, or if you have poorblood circulation.

(iii) lf discomfort persists, see your doctor.(iv) Do not use on moles, birthmarks, warts with hair growing fromthem, genital warts, or warts on the face or mucous membranes.

(2) For any product formulated in a flammable vehicle.(i)The labeling should contain an appropriate flammability signalword, e.g.“extremely flammable",“flammable".“combustible”consistent with 16 CFR 1500.3(b)(10).(ii) Keep away from fire or flame.

Section 50565-1 (50565-1)

KEEP OUT OF CHILDREN

Section 50570-1 (50570-1)

Do not use this product on irritated skin, on any area that is

infected or reddened, if you are a diabetic, or if you have poor

blood circulation.

Section 51727-6 (51727-6)

Salicylic acidTea tree oilCepress leaf extractSaffron

GlycerinArgan oilVitamin E

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Fast HealingTransparentWaterproofNon-DryingDrug-Free

Section 55106-9 (55106-9)

Salicylic Acid 5%

For the removal of common warts.


Advanced Ingredient Data


Raw Label Data

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