CBD UNLIMITED MISTX TOPICAL ANALGESIC

CBD UNLIMITED MISTX TOPICAL ANALGESIC by

Drug Labeling and Warnings

CBD UNLIMITED MISTX TOPICAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by Signature Formulations LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CBD UNLIMITED MISTX TOPICAL ANALGESIC- menthol and camphor spray 
Signature Formulations LLC

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 MISTX TOPICAL ANALGESIC

Active ingredient

Menthol USP 5%
Camphor 3.25%

Purpose

Topical Analgesic

Inactive ingredients

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

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

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

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. 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: 

CBD UNLIMITED INC

Principal Display Panel

CBD UNLIMITED MISTX 

TOPICAL ANALGESIC

1 fl. oz. (30mL) Spray

CBD UNLIMITED MISTX TOPICAL ANALGESIC 
menthol and camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69257-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 mL
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	3.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CLOVE OIL (UNII: 578389D6D0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69257-213-30	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/12/2019	04/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/12/2019	04/25/2019

Labeler - Signature Formulations LLC (079126258)

Registrant - Signature Formulations LLC (079126258)

Establishment
Name	Address	ID/FEI	Business Operations
Signature Formulations LLC		079126258	MANUFACTURE(69257-213)

Revised: 4/2019

Document Id: 424e0c16-0126-4512-9b7d-bf399c874ef9

34390-5

Set id: d869dd0a-02ac-4eac-89bc-2dab7f629893

Version: 2

Effective Time: 20190425