Active Ingredient
Trolamine Salicylate - 10%
Teds Topical Pain Gel Roll On
FDA Label NDC 58133-211
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Teds Topical Pain Gel Roll On (NDC 58133-211). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, allergy alert, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 area
- massage into painful area until thoroughly absorbed
- into skin
- repeat as necessary, but no more than 3 to 4 times daily
children 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.
Package Labeling
Tedsronon (Tedsrollon)
Rollonbox (Rollonbox)
* Please review the disclaimer below.
