CBD UNLIMITED TOPICAL ANALGESIC- menthol and camphor spray

CBD UNLIMITED TOPICAL ANALGESIC by

Drug Labeling and Warnings

CBD UNLIMITED TOPICAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by ENDEXX CORPORATION, Velocity Production and Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol USP 5%
Camphor 3.25%

Purpose

Topical Analgesic

Uses

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

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 flame or while smoking

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

Keep Out of Reach of Children

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

Directions:

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

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

INGREDIENTS AND APPEARANCE

CBD UNLIMITED TOPICAL ANALGESIC 
menthol and camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73045-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 mL
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	325 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CLOVE OIL (UNII: 578389D6D0)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
Cannabidiol (UNII: 19GBJ60SN5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73045-004-01	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/05/2020
2	NDC: 73045-004-02	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/05/2020
3	NDC: 73045-004-03	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/05/2020

Labeler - ENDEXX CORPORATION (002119594)

Registrant - ENDEXX CORPORATION (002119594)

Establishment
Name	Address	ID/FEI	Business Operations
Velocity Production and Packaging		081076893	manufacture(73045-004)