FDA.reportPublic FDA data

CBD UNLIMITED MISTX TOPICAL ANALGESIC

Manufacturer
ENDEXX CORPORATION
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:24

Label at a glance#

ProductCBD UNLIMITED MISTX TOPICAL ANALGESIC
Active ingredientMENTHOL, CAMPHOR OIL
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age & older. Spray a thin flim over affected area not more than 3 to 4 times daily: massage not necessary, for children 12 years or younger, consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 5%
Camphor 3.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica Oil, Clove Bud Oil, Eucalyptus Globus Oil, Hemp, Isopropyl Alcohol, MSM (Methylsulfonylmethane), Peppermint Oil, Sweet Birch Oil.

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.

Flammable: Keep away from excessive heat or open flame.

Do not use on wounds or damaged skin.

When using this product: Avoid contact with the eyes. Do not bandage tightly.

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

If pregnant or breast-feeding ask a health 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.

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

Adults and children 12 years of age & older. Spray a thin flim over affected area not more than 3 to 4 times daily: massage not necessary, for children 12 years or younger, consult a doctor.

Distributed By: 

SPL UNCLASSIFIED SECTION

CBD UNLIMITED INC

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CBD UNLIMITED MISTX 

TOPICAL ANALGESIC

1 fl. oz. (30mL) Spray

Label-1Label-1

Label-2
Label-2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73045-002-302022-07-29C16284748780-1e4f33bdf-aa40-d8a0-e053-dadaa90a6e4eCBD UNLIMITED MISTX TOPICAL ANALGESIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73045-002-30CBD UNLIMITED MISTX TOPICAL ANALGESIC30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73045-002CBD UNLIMITED MISTX TOPICAL ANALGESIC (MENTHOL AND CAMPHOR) SPRAY [ENDEXX CORPORATION]3Legacy NDC, 1 package rows20210127_dec993b7-dda4-4606-aa2f-1135d55874c2.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73045-00273045-002-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEMPTD1MUT01Q7IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CLOVE OIL578389D6D0IACT
EUCALYPTUS OIL2R04ONI662IACT
ISOPROPYL ALCOHOLND2M416302IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEPPERMINT OILAV092KU4JHIACT
METHYL SALICYLATELAV5U5022YIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR OIL75IZZ8Y727ACTIB

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
b9bf6fb7-4d1d-fc30-e053-2995a90aa75cdec993b7-dda4-4606-aa2f-1135d55874c22021-01-25WarningsExact identifier
spl id: b9bf6fb7-4d1d-fc30-e053-2995a90aa75c
spl set id: dec993b7-dda4-4606-aa2f-1135d55874c2

Reported adverse events (FAERS/openFDA)#

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