CBD UNLIMITED BALM TOPICAL ANALGESIC- menthol cream

CBD UNLIMITED BALM TOPICAL ANALGESIC by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

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

Warnings:

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

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

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

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

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INGREDIENTS AND APPEARANCE

CBD UNLIMITED BALM TOPICAL ANALGESIC 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73045-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	125 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANNABIDIOL (UNII: 19GBJ60SN5)
OLIVE OIL (UNII: 6UYK2W1W1E)
HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
GRAPE SEED OIL (UNII: 930MLC8XGG)
Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S)
Clove Oil (UNII: 578389D6D0)
Lavender Oil (UNII: ZBP1YXW0H8)
East Indian Lemongrass Oil (UNII: UP0M8M3VZW)
Methyl Salicylate (UNII: LAV5U5022Y)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73045-003-01	60 mL in 1 JAR; 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 & Packaging		081076893	MANUFACTURE(73045-003)