NDC 58133-210 Teds Topical Pain Cream

Methyl Salicylate 10%

NDC Product Code 58133-210

NDC 58133-210-03

Package Description: 85 g in 1 TUBE

NDC Product Information

Teds Topical Pain Cream with NDC 58133-210 is a a human over the counter drug product labeled by Cosmetic Specialty Labs, Inc.. The generic name of Teds Topical Pain Cream is methyl salicylate 10%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cosmetic Specialty Labs, 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.

Teds Topical 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.

  • METHYL SALICYLATE 10 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.

  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • WATER (UNII: 059QF0KO0R)
  • RESVERATROL (UNII: Q369O8926L)
  • SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
  • SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMER (UNII: K9R4VJQ1IB)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

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: Cosmetic Specialty Labs, Inc.
Labeler Code: 58133
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.

Teds Topical Pain Cream Product Label Images

Teds Topical 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

Methyl Salicylate - 10%

Purpose

Topical Pain Relief

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruises and • sprains

Warnings

For external use only​

Allergy Alert

If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.

Do Not Use

  • On wounds or damaged skinwith a heating pad

Ask A Physician Before Use If

  • You have redness over the affected area

When Using This Product

​ • use only as directed • avoid contact with eyes and muscous membranes • do not bandage tightly

Stop Use And Ask A Physician 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 • pregnant or breast-feeding

Keep Out Of Reach Of The Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

  • Use only as directed​adults and children 2 years of age and older:apply to affected area not more than 3 or 4 times dailychildren under 2 years of age: consult a physician

Other Information

Store at 20ºC to 25ºC (68ºF - 77ºF)

Inactive Ingredients:

Aqua (deionized water), Arnica Montana (arnica) Extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, PEG-100 stearate, phenoxyethanol, polysorbate 20, resveratrol, sodium laurylglucosides, hydroxypropylsulfonate, sorbitan olivate, stearic acid

* Please review the disclaimer below.

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