FDA.reportPublic FDA data

CBD UNLIMITED BODY SPRAY

Manufacturer
ENDEXX CORPORATION | Velocity Production and 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 TOPICAL ANALGESIC
Active ingredientMENTHOL, CAMPHOR OIL
Label structure8 sections

Indications and uses

Temporary relief from minor aches and pains of muscles & joints associated with: arthritis, simple backache, strains, sprains

Dosage and administration

FOR EXTERNAL USE ONLY: Shake Before Using Adults and children 12 years of age and older: Spray on affected areas 1 to 4 times daily. Avoid contact with eyes and mouth.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 5%
Camphor 3.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of muscles & joints associated with: arthritis, simple backache, strains, sprains

Warnings:

WARNINGS SECTION

 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 flame or while smoking

If pregnant or breast-feeding, ask a healthcare professional before use 

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

FOR EXTERNAL USE ONLY:

Shake Before Using

Adults and children 12 years of age and older:

Spray on affected areas 1 to 4 times daily.

Avoid contact with eyes and mouth.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Arnica Extract (Glycerin, Water, Arnica Montana Flower Extract), Clove Bud Oil, Eucalyptus Globulus Leaf Oil, Hemp-Derived Cannabidiol Isolate, Isopropyl Alcohol, Methylsulfonylmethane (MSM), Wintergreen Oil (Methyl Salicylate)

Principal Display Panel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73045-004-012022-07-29C16284748780-1e4f33bdf-b307-d8a0-e053-dadaa90a6e4eCBD UNLIMITED BODY SPRAY
73045-004-022022-07-29C16284748780-1e4f33bdf-b307-d8a0-e053-dadaa90a6e4eCBD UNLIMITED BODY SPRAY
73045-004-032022-07-29C16284748780-1e4f33bdf-b307-d8a0-e053-dadaa90a6e4eCBD UNLIMITED BODY SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73045-004-01CBD UNLIMITED TOPICAL ANALGESIC15 mL in 1 BOTTLE, SPRAYSPRAY151
73045-004-02CBD UNLIMITED TOPICAL ANALGESIC30 mL in 1 BOTTLE, SPRAYSPRAY301
73045-004-03CBD UNLIMITED TOPICAL ANALGESIC60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73045-004CBD UNLIMITED TOPICAL ANALGESIC (MENTHOL AND CAMPHOR) SPRAY [ENDEXX CORPORATION]1Legacy NDC, 3 package rows20200508_8dbebe05-1991-4b43-8ef3-60d66cfd75a0.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
73045-00473045-004-01, 73045-004-02, 73045-004-03

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
MENTHOLL7T10EIP3AACTIB
CAMPHOR OIL75IZZ8Y727ACTIB
ISOPROPYL ALCOHOLND2M416302IACT
EUCALYPTUS OIL2R04ONI662IACT
CLOVE OIL578389D6D0IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
Dimethyl Sulfone9H4PO4Z4FTIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
Cannabidiol19GBJ60SN5IACT

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
cf99d331-cacb-4787-8982-009141f62edd8dbebe05-1991-4b43-8ef3-60d66cfd75a02020-05-05WarningsExact identifier
spl id: cf99d331-cacb-4787-8982-009141f62edd
spl set id: 8dbebe05-1991-4b43-8ef3-60d66cfd75a0

Reported adverse events (FAERS/openFDA)#

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