FDA.reportPublic FDA data

HERSTAT PLUS Cold Sore Treatment

Manufacturer
Herstat (USA) Inc.
Effective date
2025-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:58:39

Label at a glance#

ProductHERSTAT PLUS Cold Sore Treatment
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

Indications and uses

Treats Cold Sores Temporarily relieves pain and itching associated with Cold Sores / Fever Blisters

Dosage and administration

Wash hands well before and after applying. Smooth a small amount onto the affected area. Adults and children 2 years of age and older: Apply to the affected area at least 5 times per day. Children between 2 and 12 years of age - Apply with adult supervision. Children under 2 years of age: Do not use.

Storage and handling

Close cap tightly and store in a cool, dry place.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Menthol 0.1%

PURPOSE

OTC - PURPOSE SECTION

Cold Sore / Fever BlisterTreatment

Pain reliever

USES

INDICATIONS & USAGE SECTION

Treats Cold Sores Temporarily relieves pain and itching associated with Cold Sores / Fever Blisters

WARNINGS

WARNINGS SECTION

For external use only.

When using this product:

OTC - WHEN USING SECTION

When using this product do not use in or around the eyes. Do not use if allergic to bee byproducts. Test on a small area before use.

  • Bee Propolis, Eucalyptus Oil and Thyme Oil may cause skin irritation.
Stop use and ask a doctor if:

OTC - STOP USE SECTION

• Condition worsens.

• Symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Wash hands well before and after applying. Smooth a small amount onto the affected area. Adults and children 2 years of age and older: Apply to the affected area at least 5 times per day.

Children between 2 and 12 years of age - Apply with adult supervision. Children under 2 years of age: Do not use.

OTHER

STORAGE AND HANDLING SECTION

Close cap tightly and store in a cool, dry place.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Almond Oil, Beeswax, Castor Seed Oil, Eucalyptus Leaf Oil, Glyceryl Oleate, Glyceryl Rosinate, Olive Oil, Purified Bee Propolis Extract, Thyme Leaf Oil.

QUESTIONS?

OTC - QUESTIONS SECTION

Questions? Call (307) 201-5478 or go to www.herstat.com

Herstat Cold Sore Treatment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Herstat®

Herstat Cold Sore Treatment


0.7 OZ (2g) Net Weight

LabelLabel

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2604563camphor 3 % / menthol 0.1 % Topical OintmentPSN5
2604563camphor 0.03 MG/MG / menthol 0.001 MG/MG Topical OintmentSCD5
2604563camphor 3 % / menthol 0.1 % Topical OintmentSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90100-221-022024-01-30C16284748780-11030e365-4bc9-111a-e063-dadaa90a10e2HERSTAT PLUS Cold Sore Treatment Moisturizing Lip Care Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90100-221-02HERSTAT PLUS Cold Sore Treatment2 g in 1 TUBEOINTMENT25
90100-221-02HERSTAT PLUS Cold Sore Treatment1 in 1 CARTONOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90100-221HERSTAT PLUS COLD SORE TREATMENT (CAMPHOR, MENTHOL) OINTMENT [HERSTAT (USA) INC.]5Current NDC, Legacy NDC, 2 package rows20250406_e20ea714-663d-c4ac-e053-2a95a90a5ecc.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90100-22190100-221-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
YELLOW WAX2ZA36H0S2VIACT
EUCALYPTUS OIL2R04ONI662IACT
ALMOND OIL66YXD4DKO9IACT
PROPOLIS WAX6Y8XYV2NOFIACT
MENTHOLL7T10EIP3AACTIB
THYME OIL2UK410MY6BIACT
GLYCERYL OLEATE4PC054V79PIACT
GLYCERYL ROSINATESD112V492JIACT
OLIVE OIL6UYK2W1W1EIACT

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
HERSTAT PLUS Cold Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e20ea714-663d-c4ac-e053-2a95a90a5ecc2025-01-18WarningsExact identifier
ndc (package): 90100-221-02
ndc (product): 90100-221
ndc11 (package): 90100022102
spl id: 2995ae00-d286-0fea-e063-6294a90a2c4b
spl set id: e20ea714-663d-c4ac-e053-2a95a90a5ecc

Reported adverse events (FAERS/openFDA)#

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