SPL v1
SPL
SPL Set ID 3a5b64a3-b19e-8b1a-e063-6294a90a6641
Route
TOPICAL
Published
Effective Date 2025-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 g) Lactic Acid (4.5 g)
Inactive Ingredients
Cymbopogon Citratus Leaf Oil Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Polyethylene Glycol 400 Water Pentylene Glycol Oleth-20 Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-20

Description

SALICYLIC ACID 15.00% LACTIC ACID 4.50%


Medication Information

Warnings and Precautions

WarningsFor external use only.keep away from fire and flame.only use on affected area.

Indications and Usage

for the removal of common andplantar warts o the common wart is easilyrecognized by the rough"cauliflower-like"appearance of the surface o the plantarwart is recognized by its location only onthe bottom of the foot,its tenderness andthe interruption of the footprint pattern

Dosage and Administration

wash the affected areamay soak the wart in warm water for 5minutes e dry area thoroughly e usingthe applicator(brush or cotton swab), applyone drop at a time to sufficiently cover eachwart e allow it to fully absorb and let dryrepeat this procedure once or twicedaily as needed (until the wart is removed)for up to 12 weeks

Description

SALICYLIC ACID 15.00% LACTIC ACID 4.50%

Section 50565-1

keep out of reachof children, if swallowed, get medical helpor contact a Poison Control Center rightaway.

Section 50567-7

When using this product:e avoidcontact with eyes. lf the product gets intothe eye,flush with water for 15 minutes avoid inhaling vapors o cap the bottletightly e out of direct sunlight and storeat room temperature away from heat

Section 50570-1

Do not use: on irritated skin or on anyarea that is infected or reddened o onmoles, birthmarks, warts with hair growingfrom them, warts on the face or mucousmembranes

Section 51727-6

Inactive ingredients: ®Alcohol, Propylene Glycol, Water, PentyleneGlycol, Oleth-20, Peg-40 HydrogenatedCastor Oil, Cymbopogon Citratus Leaf Oil,Polyethylene Glycol 400

Section 51945-4

Section 55105-1

Wart remover

Section 55106-9

SALICYLIC ACID 15.00%

LACTIC ACID 4.50%


Structured Label Content

Indications and Usage (34067-9)

for the removal of common andplantar warts o the common wart is easilyrecognized by the rough"cauliflower-like"appearance of the surface o the plantarwart is recognized by its location only onthe bottom of the foot,its tenderness andthe interruption of the footprint pattern

Dosage and Administration (34068-7)

wash the affected areamay soak the wart in warm water for 5minutes e dry area thoroughly e usingthe applicator(brush or cotton swab), applyone drop at a time to sufficiently cover eachwart e allow it to fully absorb and let dryrepeat this procedure once or twicedaily as needed (until the wart is removed)for up to 12 weeks

Warnings and Precautions (34071-1)

WarningsFor external use only.keep away from fire and flame.only use on affected area.

Section 50565-1 (50565-1)

keep out of reachof children, if swallowed, get medical helpor contact a Poison Control Center rightaway.

Section 50567-7 (50567-7)

When using this product:e avoidcontact with eyes. lf the product gets intothe eye,flush with water for 15 minutes avoid inhaling vapors o cap the bottletightly e out of direct sunlight and storeat room temperature away from heat

Section 50570-1 (50570-1)

Do not use: on irritated skin or on anyarea that is infected or reddened o onmoles, birthmarks, warts with hair growingfrom them, warts on the face or mucousmembranes

Section 51727-6 (51727-6)

Inactive ingredients: ®Alcohol, Propylene Glycol, Water, PentyleneGlycol, Oleth-20, Peg-40 HydrogenatedCastor Oil, Cymbopogon Citratus Leaf Oil,Polyethylene Glycol 400

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Wart remover

Section 55106-9 (55106-9)

SALICYLIC ACID 15.00%

LACTIC ACID 4.50%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)