FDA.reportPublic FDA data

Blister Balm

Manufacturer
Floratech Botanicals, LLC
Effective date
2018-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:10

Label at a glance#

ProductBlister Balm
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For relief of pain and itching associated with cold sore and fever blister outbreaks. Intense and immediate blocking of cold sore and gever blister symptoms.

Dosage and administration

Adults and children 2 years of age and older. Apply to the afftected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

External analgesic

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External Analgesic - cold sore or fever blister treatment

Uses:

INDICATIONS & USAGE SECTION

For relief of pain and itching associated with cold sore and fever blister outbreaks.

Intense and immediate blocking of cold sore and gever blister symptoms.

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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 immediately. (1-800-222-1222)

OTC - STOP USE SECTION

Stop use and ask doctor if condition worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

When using this product avoid contact with the eyes

keep out of Reach of children. If swallowed, get medical help or contact a poison control center immediately. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older. Apply to the afftected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

camphor

clove (syzygium aromaticum) leaf oil

eucalyptus globulus leaf oil

hydrolyzed jojoba esters

isopropyl jojobate

jojoba (simmondsia chinensis) esters

jojoba alcohols

lemon balm (melissa officinalis) oil

peppermint (menthe piperita) oil

rose geranium (pelargonium graveolens) oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
418610menthol 1 % Topical OintmentPSN2
418610menthol 0.01 MG/MG Topical OintmentSCD2
418610menthol 1 % Topical OintmentSY2
418610menthol 1 % Topical StickSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70996-003-012021-01-29C16284748780-1ba0f9c33-4c5b-a910-e053-dadaa90a0b85442e8091-cbf6-4c61-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70996-003-01Blister Balm2.6 g in 1 TUBESALVE2.62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70996-003BLISTER BALM (MENTHOL 1%) SALVE [FLORATECH BOTANICALS, LLC]2Legacy NDC, 1 package rows20181107_442e8091-cbf6-4c61-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70996-00370996-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
LEMON BALM OILMJ76269K9SIACT
ALPROSTADIL ISOPROPYL ESTER8THV3YDD6AIACT
MENTHOLL7T10EIP3AACTIB
CLOVE LEAF OILVCA5491KVFIACT
PELARGONIUM ROSEUM OILXSN2Q85DC6IACT
PEPPERMINT OILAV092KU4JHIACT
HYDROGENATED JOJOBA OIL7F674YQ5SOIACT

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
4ec00f03-53a9-42c6-b844-abe00bc60af4442e8091-cbf6-4c61-e054-00144ff8d46c2018-11-06WarningsExact identifier
spl id: 4ec00f03-53a9-42c6-b844-abe00bc60af4
spl set id: 442e8091-cbf6-4c61-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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