SPL v1
SPL
SPL Set ID 3e4c55ae-355d-176b-e063-6394a90a1bc6
Route
TOPICAL
Published
Effective Date 2025-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (8 g)
Inactive Ingredients
Alcohol Sophora Flavescens Root Lithospermum Incisum Whole Angelica Dahurica Var. Formosana Whole Brucea Javanica Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-14

Description

Active ingredrents Salicylic acid 8% w/w


Medication Information

Warnings and Precautions

Warnings o For exernal use only e Keep away fromheat or flame

Indications and Usage

Directlons @Wash the affected area osoak the.wartsin warm water for $ minutes aind dry it thoroughly@Apply one drop at a time with the applicator to cov,er the warts completely m, Allow to dry, use self-adhesive cushloning pads to cover the warts if deslredeRepeat this process once or twice dally as neededfor up to 12 weeks, untll the warts is removed (Ncte.For external use, and can not be applied to healthy Skin)

Dosage and Administration

Repeat this process once or rwice dally as neededfor up to 12 weeks, untll the warts is remowed

Description

Active ingredrents Salicylic acid 8% w/w

Section 50565-1

Keep out of reach ofchildren, lfswallowed, get medical help or contact a Poison controt center right a-way

Section 51727-6

Brucea javanica, Radix Angelica,Lithospermum, Sophora, Antiseptic substance

Section 51945-4

Section 55105-1

Uses For The removai ol s corns, calluses, piantar warts, filat warts, comman warts (less than 5 mmin stze).

Section 55106-9

Active ingredrents

Salicylic acid 8% w/w

Section 60561-8

lf you have diabetes if you have poor circulatlon on lrrltated skin or anyarea that isinfected or reddened on moles, birhmarks


Structured Label Content

Indications and Usage (34067-9)

Directlons @Wash the affected area osoak the.wartsin warm water for $ minutes aind dry it thoroughly@Apply one drop at a time with the applicator to cov,er the warts completely m, Allow to dry, use self-adhesive cushloning pads to cover the warts if deslredeRepeat this process once or twice dally as neededfor up to 12 weeks, untll the warts is removed (Ncte.For external use, and can not be applied to healthy Skin)

Dosage and Administration (34068-7)

Repeat this process once or rwice dally as neededfor up to 12 weeks, untll the warts is remowed

Warnings and Precautions (34071-1)

Warnings o For exernal use only e Keep away fromheat or flame

Section 50565-1 (50565-1)

Keep out of reach ofchildren, lfswallowed, get medical help or contact a Poison controt center right a-way

Section 51727-6 (51727-6)

Brucea javanica, Radix Angelica,Lithospermum, Sophora, Antiseptic substance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses For The removai ol s corns, calluses, piantar warts, filat warts, comman warts (less than 5 mmin stze).

Section 55106-9 (55106-9)

Active ingredrents

Salicylic acid 8% w/w

Section 60561-8 (60561-8)

lf you have diabetes if you have poor circulatlon on lrrltated skin or anyarea that isinfected or reddened on moles, birhmarks


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)