NDC 70554-229 Feelgood Lab Natural Pain Cream

Menthol

NDC Product Code 70554-229

NDC 70554-229-00

Package Description: 1 TUBE in 1 BOX > 50 mL in 1 TUBE

NDC Product Information

Feelgood Lab Natural Pain Cream with NDC 70554-229 is a a human over the counter drug product labeled by The Feel Good Lab, Llc. The generic name of Feelgood Lab Natural Pain Cream is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: The Feel Good Lab, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Feelgood Lab Natural Pain Cream 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)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ANNATTO (UNII: 6PQP1V1B6O)
  • 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)
  • CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
  • TURMERIC (UNII: 856YO1Z64F)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC)
  • 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.

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: 05-26-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Feelgood Lab Natural Pain Cream Product Label Images

Feelgood Lab Natural Pain Cream 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%

Purpose

Topical analgesic

Indications

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

Warnings:

  • For external use only.Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult a physician.

Keep Out Of Reach Of Children.

  • If swallowed, consult  physician.Do not apply to wounds or damages skin.Do not bandage tightly.

If Pregnant Or Breastfeeding,

  • Consult physician prior to use.

Directions

  • Adults and children two years of age on older: Apply to affected area not more than three to four times daily.Children under two years of age: consult a physician.

Additional Information

Store at room temperature.

Other Ingredients

Achillea Mellefolim (Yarrow) Extract, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Bixa Orellana (Annatto) Extract, Beeswax, Boswellia Serrata Extract,Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Myristoleate, Chondroitin Sulfate, Curcuma Longa (Turmeric) Root Extract, Gluconolactone, Glucosamine HCL, Glycerin, Glyceryl Stearate, Harpagophytum Procumbens (Devil's Claw) Root Extract, Helianthus Annuus (Sunflower), 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.