CBD UNLIMITED BALM TOPICAL ANALGESIC

Manufacturer
ENDEXX CORPORATION | Velocity Production & Packaging
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:03

Label at a glance#

ProductCBD UNLIMITED BALM TOPICAL ANALGESIC
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

 For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, backache, strains and sprains.

Dosage and administration

Adults and children 12 years of age and older: Apply on affected areas 1 to 4 times daily. Avoid contact with eyes & mouth.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

 For the temporary relief of minor aches and
pains of muscles and joints associated with arthritis, backache, strains and sprains.

Warnings:

WARNINGS SECTION

Warnings: For external use only.

When using this product:
• use only as directed

• do not bandage tightly or use with a heating pad

• avoid contact with eyes and mucous membranes

• do not apply to wounds or damaged, broken or irritated skin

• do not spray onto face

• avoid inhaling spray mist and fumes

Stop use and ask doctor if

• condition worsens

• redness is present

• irritation develops

• symptoms persist for more than 7 days or clears up and occurs again within a few days

Flammable

• do not use near heat or open _ame or while smoking

If pregnant or breast-feeding, ask a healthcare

professional before use.

Keep out of the reach of children

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Apply on affected areas 1 to 4 times daily.

Avoid contact with eyes & mouth.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Arnica Extract (Glycerin, Water, Arnica Montana Flower Extract), Beeswax, Clove Bud Oil, Grapeseed Oil, Hemp-Derived Cannabadiol Isolate, Hemp Seed Oil, Lavender Oil, Methylsulfonylmethane (MSM), MCT Coconut Oil, Lemongrass Oil, Moringa Oil, Sweet Birch Oil

Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73045-003-012022-07-29C16284748780-1e4f33bdf-9e34-d8a0-e053-dadaa90a6e4eCBD UNLIMITED TOPICAL ANALGESIC BALM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73045-003-01CBD UNLIMITED BALM TOPICAL ANALGESIC60 mL in 1 JARCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73045-003CBD UNLIMITED BALM TOPICAL ANALGESIC (MENTHOL) CREAM [ENDEXX CORPORATION]1Legacy NDC, 1 package rows20200508_2b77e774-bee6-44fe-bd27-a1b44b3e32e8.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73045-00373045-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

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
5e3f0c2d-a1f4-4760-9865-0ef891074df82b77e774-bee6-44fe-bd27-a1b44b3e32e82020-05-05WarningsExact identifier
spl id: 5e3f0c2d-a1f4-4760-9865-0ef891074df8
spl set id: 2b77e774-bee6-44fe-bd27-a1b44b3e32e8

Reported adverse events (FAERS/openFDA)#

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