Label: TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73155-004-31 - Packager: TRUVITALITY, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 31, 2019
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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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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
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- STOP USE
- PREGNANCY OR BREAST FEEDING
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRUVITALITY CBD MUSCLE FREEZE 4% MENTHOL
menthol gelProduct 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)