OTC Medication Information: TruVitality CBD Muscle Freeze 4% Menthol

TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL- menthol, unspecified form 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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:73155-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
PHENOXYETHANOL
PROPYLENE GLYCOL
ALOE
GLYCERIN
WATER
CARBOXYPOLYMETHYLENE
CANNABIS SATIVA SUBSP. SATIVA WHOLE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73155-004-31 1 BOTTLE, WITH APPLICATOR in 1 BOX contains a BOTTLE, WITH APPLICATOR
1 3 g in 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (73155-004-31)
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 Operations
Deenterprises, Inc. 073070083 manufacture (73155-004), pack (73155-004), label (73155-004)

Revised: 12/2019 TRUVITALITY, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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