Label: TEDS TOPICAL PAIN GEL ROLL ON- trolamine salicylate 10% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 11, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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 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

    TedsRonOnrollonbox

  • INGREDIENTS AND APPEARANCE
    TEDS TOPICAL PAIN GEL ROLL ON 
    trolamine salicylate 10% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    WATER (UNII: 059QF0KO0R)  
    RESVERATROL (UNII: Q369O8926L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-211-0385 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product03/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/21/2019
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-211)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!