CBD UNLIMITED BALMX TOPICAL ANALGESIC- menthol cream

CBD UNLIMITED BALMX TOPICAL ANALGESIC by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Inactive ingredients

Arnica Oil, Beeswax,  Clove Bud Oil, Grapeseed Oil, Hemp Isolate, Hemp Seed Oil, Lavender Oil, MSM (Methylsulfonylmethane), MCT Coconut Oil, Organic Lemongrass Oil, Organic Moringa Oil, Sweet Birch Oil.

Uses

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

Warnings:

For external use only.

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

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

Directions:

Adults and children 12 years of age & older. Rub well on affected area not more than 3 to 4 times daily. For children 12 years or younger, consult a doctor before use.

Distributed By: 

CBD UNLIMITED INC

Principal Display Panel

CBD UNLIMITED BALMX

TOPICAL ANALGESIC

2 fl. oz. (60mL) Balm

INGREDIENTS AND APPEARANCE

CBD UNLIMITED BALMX TOPICAL ANALGESIC 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73045-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
HEMP (UNII: TD1MUT01Q7)
CLOVE OIL (UNII: 578389D6D0)
COCONUT OIL (UNII: Q9L0O73W7L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73045-001-01	60 mL in 1 JAR; Type 0: Not a Combination Product	04/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/11/2019

Labeler - ENDEXX CORPORATION (002119594)

Registrant - ENDEXX CORPORATION (002119594)

Establishment
Name	Address	ID/FEI	Business Operations
Signature Formulations LLC		079126258	MANUFACTURE(73045-001)