SPL v1
SPL
SPL Set ID 438bde30-3e24-9157-e063-6294a90a1423
Route
TOPICAL
Published
Effective Date 2025-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 g)
Inactive Ingredients
Borneol Polyethylene Glycol, Unspecified Water Glycerin Podofilox

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-14

Description

SALICYLIC ACID


Medication Information

Warnings and Precautions

For external use only. Flammable.

Keep away from fire and flame.

Indications and Usage

Wash the affected area.

May soak wart in warm water for 5 minutes.

Dry area thoroughly.

Use a brush to apply a sufficient amount to cover each wart. Let it dry.

Repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks.

Dosage and Administration

Wash the affected area.

May soak wart in warm water for 5 minutes.

Description

SALICYLIC ACID

Section 50565-1

Keep out of reach of chlldren

Section 51727-6

BORNEOL

POLYETHYLENE GLYCOL, UNSPECIFIED

WATER

GLYCERIN

PODOFILOX

Section 51945-4

Section 55105-1

for the removal of common and plantar warts

Section 55106-9

SALICYLIC ACID


Structured Label Content

Indications and Usage (34067-9)

Wash the affected area.

May soak wart in warm water for 5 minutes.

Dry area thoroughly.

Use a brush to apply a sufficient amount to cover each wart. Let it dry.

Repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks.

Dosage and Administration (34068-7)

Wash the affected area.

May soak wart in warm water for 5 minutes.

Warnings and Precautions (34071-1)

For external use only. Flammable.

Keep away from fire and flame.

Section 50565-1 (50565-1)

Keep out of reach of chlldren

Section 51727-6 (51727-6)

BORNEOL

POLYETHYLENE GLYCOL, UNSPECIFIED

WATER

GLYCERIN

PODOFILOX

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for the removal of common and plantar warts

Section 55106-9 (55106-9)

SALICYLIC ACID


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)