MENTHOL

Manufacturer
The Fresh Market | Filltech USA, LLC
Effective date
2019-11-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:57:13

Label at a glance#

ProductThe Fresh Market Medicated Lip Balm Soothing With Menthol Eucalyptus Oil And Clove
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

For the temporary relief of pain and itching associated with fever blisters and cold sores.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.6%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with fever blisters and cold sores.

Warnings:

WARNINGS SECTION

For external use only.

Avoid contact with eyes

OTC - WHEN USING SECTION

if this happens, rinse thoroughly with water. If condition worsens or if symptoms persist for more than 7 days or clear up and occur again with in a few days, discontinue use and consult a doctor.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

cera alba (beeswax), camphor, cocos nucifera (coconut) oil, eucalyptus globulus leaf oil, helianthus annuus (sunflower) seed oil, lanolin, persea gratissima (avocado) oil, simmondsia chinensis (jojoba) seed oil, syzygium aromaticum (clove bud) oil, tocopherol (vitamin e), vitis vinifera (grapeseed).

Questions?

OTC - QUESTIONS SECTION

Call 866-817-4367

Distributed by:

SPL UNCLASSIFIED SECTION

The Fresh Market Greensborb, NC 27408 (866) 817-4367 www.thefreshmarket.com Made in USA 737094204594

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THE FRESH MARKET MEDICATED LIP BALM SOOTHING WITH MENTHOL EUCALYPTUS OIL AND CLOVE net wt. 0.15 oz(4g)

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medicated Lip BalmMedicated Lip Balm

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

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
53040-99653040-996-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 25 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates

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
982f8f4b-479e-57d8-e053-2995a90adb8804cec28c-63b9-49e7-8465-26b0cc7c119f2019-11-25WarningsExact identifier
spl id: 982f8f4b-479e-57d8-e053-2995a90adb88
spl set id: 04cec28c-63b9-49e7-8465-26b0cc7c119f

Reported adverse events (FAERS/openFDA)#

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