TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL- menthol gel

TruVitality CBD Muscle Freeze 4% Menthol by

Drug Labeling and Warnings

TruVitality CBD Muscle Freeze 4% Menthol by is a Otc medication manufactured, distributed, or labeled by TRUVITALITY, LLC, Deenterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 4%.

DOSAGE & ADMINISTRATION

Adults and children over 2 years: Rub a thin film over affected areas up to 4 times daily. Children under 2 years: Consult a physician.

WARNINGS

Warnings: For external use only.

When using this product: Use only as directed. Do not bandage tightly. Do not use a heating pad or device. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. Do not use with other ointments.

Flammable: Keep away from excessive heat or flame.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

INACTIVE INGREDIENT

Aloe Juice, Cannabidiol (Hemp Derived, THC-Free), Carbomer, Glycerin, MCT Coconut Oil, PhenoxyEthanol, Propylene Glycol, Water.

INDICATIONS & USAGE

Uses: Menthol provides temporary relief from minor aches and pains of sore muscles & joints associated with: simple backache, strains, sprains, bruises, cramps.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

PURPOSE

Menthol 4%: Cooling Pain Relief.

STOP USE

Stop use and ask a doctor if: Condition worsens, irritation develops, symptoms persist for over 7 days or clear up and reoccur within a few days.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding: Ask a health professional before use.

STORAGE AND HANDLING

Do not freeze. Keep lid tightly closed when not in use. Store in a cool place.

QUESTIONS

Questions or Comments?: 1-800-214-4064.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73155-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE (UNII: V5VD430YW9)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CANNABIS SATIVA SUBSP. SATIVA WHOLE (UNII: 0XTN3895NP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73155-004-31	1 in 1 BOX	01/30/2020
1		3 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2020

Labeler - TRUVITALITY, LLC (117075021)

Establishment
Name	Address	ID/FEI	Business Operations
Deenterprises, Inc.		073070083	manufacture(73155-004) , pack(73155-004) , label(73155-004)