CBD UNLIMITED TOPICAL ANALGESIC- menthol and camphor spray 
ENDEXX CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CBD UNLIMITED BODY SPRAY

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)

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CBD UNLIMITED TOPICAL ANALGESIC 
menthol and camphor spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73045-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL325 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73045-004-0115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/05/2020
2NDC:73045-004-0230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/05/2020
3NDC:73045-004-0360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/05/2020
Labeler - ENDEXX CORPORATION (002119594)
Registrant - ENDEXX CORPORATION (002119594)
Establishment
NameAddressID/FEIBusiness Operations
Velocity Production and Packaging081076893manufacture(73045-004)

Revised: 5/2020
Document Id: cf99d331-cacb-4787-8982-009141f62edd
Set id: 8dbebe05-1991-4b43-8ef3-60d66cfd75a0
Version: 1
Effective Time: 20200505
 
ENDEXX CORPORATION