NDC 72667-009 Dr Goldsons

Menthol, Methyl Salicylatw

NDC Product Code 72667-009

NDC Product Information

Dr Goldsons with NDC 72667-009 is a a human over the counter drug product labeled by Inspec Solutions Llc.. The generic name of Dr Goldsons is menthol, methyl salicylatw. The product's dosage form is cream and is administered via topical form.

Labeler Name: Inspec Solutions 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.

Dr Goldsons 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 8 g/100mL
  • METHYL SALICYLATE 30 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.

  • POTASSIUM STEARATE (UNII: 17V812XK50)
  • CURCUMA LONGA LEAF (UNII: H2HC4RY52C)
  • CETYL PHOSPHATE (UNII: VT07D6X67O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LANOLIN (UNII: 7EV65EAW6H)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • WATER (UNII: 059QF0KO0R)

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: Inspec Solutions Llc.
Labeler Code: 72667
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: 03-21-2019 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.

Dr Goldsons 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

Active IngredientsMenthol 8%Methyl Salicylate 30%

Otc - Purpose

Menthol 8% ...............................External AnalgesicMethyl Salicylate 30% ...............External Analgesic

Indications & Usage

INDICATIONS & USAGE SECTIONUses for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

WarningsFor external use onlyDo not use- on wounds or damaged skin- with heating pad

Otc - Stop Use

Stop use and ask a doctor if- condition worsens or symptoms persist for more than 7 days- symptoms clear up and occur again within a few days- excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Direction- Use only as directed- Adults and children over 12 years: Apply to affected area no more than 3 to 4 times daily.- Children 12 years or younger: ask a doctor.- Close cap tightly after use.

Inactive Ingredient

Curcuma Longa (Turmeric) Root ExtractDEA-Cetyl PhosphateGlyceryl StearateGlycerinLanolinPotassium StearateStearic AcidWater

* Please review the disclaimer below.

Previous Code
72667-008
Next Code
72667-010