SPL v1
SPL
SPL Set ID 3ca69c69-cd0b-d704-e063-6294a90ac0c8
Route
TOPICAL
Published
Effective Date 2025-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 g)
Inactive Ingredients
Polyethylene Glycol, Unspecified Glycerin Podofilox Water Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-18

Description

Salicylic acid 5%


Medication Information

Warnings and Precautions

For external use only. Flammable.Keep awayfrom fire and flame.Do not use on irritatedskin or on any area that is infected orreddened·on moles, birthmarks, warts withhair growing from them, genital warts or wartson the face or mucous membranes· if you havediabetes or poor blood circulation

Indications and Usage

avoid contact with eyes. lf product gets intothe eye,flush with water for 15minutes.·avoidinhaling vapors· cap tightly and store at roomtemperature away from heat

Dosage and Administration

wash affected area· may soak wart in warmwater for 5 minutes·dry area thoroughly· bysqueezing tube gently, apply one drop at a timeto sufficiently cover each wart*let dry·repeatthis procedure once or twice daily as needed(until wart is removed)for up to 12 weeks

Description

Salicylic acid 5%

Section 50565-1

Keep out of Reach of children

Section 51727-6

Borneol

Glycerin

Podofilox

Polyethylene Glycol

Water

Section 51945-4

Section 55105-1

Plantar wart

Corn

Calluses

Flat warts

Common wart

Section 55106-9

Salicylic acid 5%

Section 60561-8

store at room temperature* avoid excessiveheat 37°C (99°F)·skin discoloration may accurduring or after use · wipe the tip of the tubewith a paper towel between uses


Structured Label Content

Indications and Usage (34067-9)

avoid contact with eyes. lf product gets intothe eye,flush with water for 15minutes.·avoidinhaling vapors· cap tightly and store at roomtemperature away from heat

Dosage and Administration (34068-7)

wash affected area· may soak wart in warmwater for 5 minutes·dry area thoroughly· bysqueezing tube gently, apply one drop at a timeto sufficiently cover each wart*let dry·repeatthis procedure once or twice daily as needed(until wart is removed)for up to 12 weeks

Warnings and Precautions (34071-1)

For external use only. Flammable.Keep awayfrom fire and flame.Do not use on irritatedskin or on any area that is infected orreddened·on moles, birthmarks, warts withhair growing from them, genital warts or wartson the face or mucous membranes· if you havediabetes or poor blood circulation

Section 50565-1 (50565-1)

Keep out of Reach of children

Section 51727-6 (51727-6)

Borneol

Glycerin

Podofilox

Polyethylene Glycol

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Plantar wart

Corn

Calluses

Flat warts

Common wart

Section 55106-9 (55106-9)

Salicylic acid 5%

Section 60561-8 (60561-8)

store at room temperature* avoid excessiveheat 37°C (99°F)·skin discoloration may accurduring or after use · wipe the tip of the tubewith a paper towel between uses


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)