SPL v1
SPL
SPL Set ID 3eceb19d-9dc8-8d25-e063-6294a90a91ab
Route
TOPICAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15

Description

Salicylic acid 8% w/w


Medication Information

Warnings and Precautions

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

Indications and Usage

keep out of eyes, ear ;and mouth if product gets in eyes, flush with waterfor 15 minutes

Dosage and Administration

Wash the affected area , Soak the.wartsin warm water for 5 minutes aind dryit thoroughly Apply one drop at a time with the applicator to cov.er the warts completely o Allow to dry, use self adhesive cushloning pads to cover the warts if deslred@Repeat this pracess once or twice dally as neededfor up to 12 weeks, until the warts is removed (Nte.For external use, and can not be applied to healthy skin)

Description

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

ALCOHOL

SOPHORA FLAVESCENS ROOT

LITHOSPERMUM INCISUM WHOLEANGELICA DAHURICA VAR. FORMOSANA WHOLEBRUCEA JAVANICA WHOLE

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

Salicylic acid 8% w/w


Structured Label Content

Indications and Usage (34067-9)

keep out of eyes, ear ;and mouth if product gets in eyes, flush with waterfor 15 minutes

Dosage and Administration (34068-7)

Wash the affected area , Soak the.wartsin warm water for 5 minutes aind dryit thoroughly Apply one drop at a time with the applicator to cov.er the warts completely o Allow to dry, use self adhesive cushloning pads to cover the warts if deslred@Repeat this pracess once or twice dally as neededfor up to 12 weeks, until the warts is removed (Nte.For external use, and can not be applied to healthy skin)

Warnings and Precautions (34071-1)

Warnings o For exernal use only ,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)

ALCOHOL

SOPHORA FLAVESCENS ROOT

LITHOSPERMUM INCISUM WHOLEANGELICA DAHURICA VAR. FORMOSANA WHOLEBRUCEA JAVANICA WHOLE

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)

Salicylic acid 8% w/w


Advanced Ingredient Data


Raw Label Data

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