NDC 58133-211 Teds Topical Pain Gel Roll On

Trolamine Salicylate 10%

NDC Product Code 58133-211

NDC 58133-211-03

Package Description: 85 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Teds Topical Pain Gel Roll On with NDC 58133-211 is a a human over the counter drug product labeled by Cosmetic Specialty Labs, Inc.. The generic name of Teds Topical Pain Gel Roll On is trolamine salicylate 10%. The product's dosage form is gel and is administered via topical form.

Labeler Name: Cosmetic Specialty Labs, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Gel Roll On 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.

  • TROLAMINE 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.

  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • WATER (UNII: 059QF0KO0R)
  • RESVERATROL (UNII: Q369O8926L)
  • BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)
  • SALIX ALBA BARK (UNII: 205MXS71H7)

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 Gel Roll On Product Label Images

Teds Topical Pain Gel Roll On 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

Trolamine Salicylate - 10%

Purpose

Topical Pain Relief

Uses

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

Warnings

For external use only​

Allergy Alert

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When Using This Product

• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

Stop Use And Ask A Doctor If

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present• irritation develops

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Use only as directed​Adults and children over 2 years:Apply generously to affected areamassage into painful area until thoroughly absorbedinto skinrepeat as necessary, but no more than 3 to 4 times dailychildren under 2 years of age: Ask a doctor

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Caprylyl Glycol, Carbomer, Cyclomethicone, Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water, Resveratrol, Salix Alba (Willow) Bark Extract, Triethanolamine.

* Please review the disclaimer below.

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