TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL- menthol gel 
TRUVITALITY, 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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TruVitality CBD Muscle Freeze Roll-On

Menthol 4%.

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: 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.

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

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

Menthol 4%: Cooling Pain Relief.

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.

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

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

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

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TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73155-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73155-004-311 in 1 BOX01/30/2020
13 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/2020
Labeler - TRUVITALITY, LLC (117075021)
Establishment
NameAddressID/FEIBusiness Operations
Deenterprises, Inc.073070083manufacture(73155-004) , pack(73155-004) , label(73155-004)

Revised: 12/2019
Document Id: 9b053fc3-b751-b265-e053-2a95a90a117d
Set id: 8aab718e-73ab-92c7-e053-2a95a90a0950
Version: 4
Effective Time: 20191231
 
TRUVITALITY, LLC