NDC 70554-291 Feel Good Labs Sport Recovery

Menthol

NDC Product Code 70554-291

NDC 70554-291-00

Package Description: 100 mL in 1 TUBE

NDC Product Information

Feel Good Labs Sport Recovery with NDC 70554-291 is a a human over the counter drug product labeled by The Feel Good Lab, Llc. The generic name of Feel Good Labs Sport Recovery is menthol. The product's dosage form is lotion and is administered via topical form.

Labeler Name: The Feel Good Lab, Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Feel Good Labs Sport Recovery 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 12.5 mg/mL

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.

  • ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ANNATTO (UNII: 6PQP1V1B6O)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
  • TURMERIC (UNII: 856YO1Z64F)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)

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.
  • 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: The Feel Good Lab, Llc
Labeler Code: 70554
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: 02-03-2020 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: 12-31-2021 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.

Feel Good Labs Sport Recovery Product Label Images

Feel Good Labs Sport Recovery 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

Active Ingredient

Menthol 1.25%

Indications

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache.

Warnings

• For external use only.


• Avoid contact with eyes.


• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

• If swallowed, consult physician.• Do not apply to wounds or damaged skin.


• Do not bandage tightly.

If Pregnant Or Breastfeeding,

• consult physician prior to use.

Directions

  • Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a physician.

Additional Information

Store at room temperature.

Other Ingredients

Achillea Millefolium (Yarrow) Extract, Aloe Barbadensis Leaf (Aloe Vera Gel), Annatto, Aqua (Deionized Water), Arnica Montana (Arnica) Extract,


Bixa Orellana (Annatto) Extract, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Myristoleate, Curcuma Longa (Turmeric) Root Extract, Gluconolactone, Glycerin, Glyceryl Stearate, Harpagophytum Procumbens (Devil's Claw) Root Extract, Helianthus Annuus (Sunflower), Hyaluronic Acid, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Scutellaria Baicalensis (Skullcap) Root Extract, Sodium Benzoate, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Yucca Schidigera Extract

* Please review the disclaimer below.