NDC 73155-004 Truvitality Cbd Muscle Freeze 4% Menthol

Menthol

NDC Product Code 73155-004

NDC Code: 73155-004

Proprietary Name: Truvitality Cbd Muscle Freeze 4% Menthol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73155 - Truvitality, Llc
    • 73155-004 - Truvitality Cbd Muscle Freeze 4% Menthol

NDC 73155-004-31

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 3 g in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Truvitality Cbd Muscle Freeze 4% Menthol with NDC 73155-004 is a a human over the counter drug product labeled by Truvitality, Llc. The generic name of Truvitality Cbd Muscle Freeze 4% Menthol is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Truvitality, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Truvitality Cbd Muscle Freeze 4% Menthol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL, UNSPECIFIED FORM 4 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Truvitality, Llc
Labeler Code: 73155
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-04-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Truvitality Cbd Muscle Freeze 4% Menthol Product Label Images

Truvitality Cbd Muscle Freeze 4% Menthol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - 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.

Otc - 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.

Otc - Purpose

Menthol 4%: Cooling Pain Relief.

Otc - 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.

Otc - 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.

Otc - Questions

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

* Please review the disclaimer below.

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