FDA.reportPublic FDA data

87786-007

Manufacturer
Wenzhou Yuyuan Pharmaceutical Co., Ltd.
Effective date
2026-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:36:07

Label at a glance#

ProductTerraCalm Wart Removal Gel
Active ingredientSALICYLIC ACID
Label structure12 sections

Dosage and administration

Wash the affected area.(Soaking in warm water for 5 minutes may help.) Dry thoroughly. Apply a small amount to cover each wart. Let it dry. Repeat twice daily as needed, for up to 12 weeks.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 5%

Purpose

OTC - PURPOSE SECTION

Wart remover

Use

INDICATIONS & USAGE SECTION

For the removal of common warts, which have a rough, cauliflower-like appearance.

Warnings

WARNINGS SECTION

For external use only-
Avoid contact with eyes.
If the product gets into the eyes, rinse with water for 15 minutes.Avoid inhaling vapors.

Do not use

OTC - DO NOT USE SECTION

Don't use on irritated or infected skin, or reddened areas.
If you are diabetic or have poor blood circulation, consult a doctor before use.
Don't use on birthmarks, warts with hair growth or moles.

When Using

OTC - WHEN USING SECTION

If pregnant or breast-feeding,consult a health professional before use.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if discomfort persists.

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if discomfort persists.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek immediate medical help or contact a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash the affected area.(Soaking in warm water for 5 minutes may help.)
Dry thoroughly.
Apply a small amount to cover each wart. Let it dry.
Repeat twice daily as needed, for up to 12 weeks.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Polyethylene Glycol,Glycerin, Borneol, Methylparaben, Chlorhexidine

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87786-00787786-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
CHLORHEXIDINER4KO0DY52LIACT
BORNEOLM89NIB437XIACT
METHYLPARABENA2I8C7HI9TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerraCalm Wart Removal GelSALICYLIC ACID 5% WART REMOVAL GELWenzhou Yuyuan Pharmaceutical Co., Ltd.550a761b-dac9-d4cf-e063-6294a90a346b2026-06-24WarningsExact identifier
ndc (package): 87786-007-01
ndc (product): 87786-007
ndc11 (package): 87786000701
spl id: 550a761b-daca-d4cf-e063-6294a90a346b
spl set id: 550a761b-dac9-d4cf-e063-6294a90a346b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.