NDC 58223-908 Joint And Muscle Cream

Menthol

NDC Product Code 58223-908

NDC 58223-908-01

Package Description: 1 TUBE in 1 CARTON > 118.294 mL in 1 TUBE

NDC Product Information

Joint And Muscle Cream with NDC 58223-908 is a a human over the counter drug product labeled by Hto Nevada Inc.. The generic name of Joint And Muscle Cream is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Hto Nevada Inc.

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.

Joint And Muscle 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, UNSPECIFIED FORM 1.8 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CANNABIGEROL (UNII: J1K406072N)
  • GUAR GUM (UNII: E89I1637KE)
  • IMIDUREA (UNII: M629807ATL)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Hto Nevada Inc.
Labeler Code: 58223
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: 03-22-2021 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.

Joint And Muscle Cream Product Label Images

Joint And Muscle 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

Otc - Purpose

Active Ingredients:PurposeMenthol USP 1.8%Topical Analgesic

Indications & Usage

USES:  Temporarily relieves minor pain

Warnings

WARNINGS: For external use only

Do Not Use:

  • On large areas of the bodyon cut, swollen or irritated skinon open woundsfor longer than one week without consulting a health practitioner.

Discontinue Use And Consult A Healthcare Practitioner If:

  • You have skin irritation or signs of injury, such as redness, pain, swelling or blistering where product is appliedcondition worsenssymptoms last longer than one week

When Using This Product:

  • Use only as directedread and follow directions on this labeldo not apply bandage to affected area after usedo not apply heat after use; do not use with other topical products on the same area at the same time.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding: consult a healthcare practitioner before use.

Keep Out Of Reach Of Children.

If swallowed, seek medical help or contact the Poison Control Center immediately.

Suggested Use:

Rub 1.1 grams (approximately ¼ tsp) of cream into the affected area as needed.

Inactive Ingredient

Other Ingredients:  Purified Water, MSM (Methylsulfonymethane), Glyceryl Stearate and PEG-100 Stearate, Cetearyl Alcohol and Ceteareth 20, Glyceryl Dilaurate, Magnesium Sulfate, Glycerine, Propylene Glycol, Cannabidiol (CBD) (Hemp Flower Extract), Isopropyl Mytistate, Cannabigerol (CBG) (Hemp Flower Extract), Guar Gum, Imidazolidinyl Urea, Methylparaben, Propylparaben

* Please review the disclaimer below.