SPL v1
SPL
SPL Set ID 438a5d21-4461-84df-e063-6294a90aa66c
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 mg)
Inactive Ingredients
Disodium Phosphate Cyclodextrin Centella Asiatica Propylene Glycol Cellulose Gum Hydroxyethylcellulose Polyisobutylene (1300 Mw) Polysorbate 60 Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

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

Description

Salicylic acid


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

wash affected areadry area thoroughlyapply the patch directly over the wart or tagrepeat this procedure every 48 hours as needed, until the wart or tag is removed,for up to 12 weeks

Dosage and Administration

apply the patch directly over the wart or tag

repeat this procedure every 48 hours as needed, until the wart or tag is removedfor up to 12 weeks

Description

Salicylic acid

Section 50565-1

Keep out of reach of children, lf swallowed, get medical help or contact aPoison Control Center(1-800-222-1222)right away.

Section 51727-6

Inactive ingredients Cellulose Gum, Propylene Glycol, Cyclodextrin, MelaleucaAlternifolia (Tea Tree) Leaf Oil, Centella Asiatica Extract, Polyisobutene,Hydroxyethylcellulose, Disodium Phosphate, polysorbate 60

Section 51945-4

Section 55105-1

for the removal of warts and tags

Section 55106-9

Salicylic acid


Structured Label Content

Indications and Usage (34067-9)

wash affected areadry area thoroughlyapply the patch directly over the wart or tagrepeat this procedure every 48 hours as needed, until the wart or tag is removed,for up to 12 weeks

Dosage and Administration (34068-7)

apply the patch directly over the wart or tag

repeat this procedure every 48 hours as needed, until the wart or tag is removedfor up to 12 weeks

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children, lf swallowed, get medical help or contact aPoison Control Center(1-800-222-1222)right away.

Section 51727-6 (51727-6)

Inactive ingredients Cellulose Gum, Propylene Glycol, Cyclodextrin, MelaleucaAlternifolia (Tea Tree) Leaf Oil, Centella Asiatica Extract, Polyisobutene,Hydroxyethylcellulose, Disodium Phosphate, polysorbate 60

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for the removal of warts and tags

Section 55106-9 (55106-9)

Salicylic acid


Advanced Ingredient Data


Raw Label Data

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