Label: TEDS TOPICAL PAIN CREAM- methyl salicylate 10% cream

  • 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

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  • 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 skin
    • with 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 daily

    children 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

  • Package Labeling

    Tedspaincream

  • INGREDIENTS AND APPEARANCE
    TEDS TOPICAL PAIN CREAM 
    methyl salicylate 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-210-0385 g in 1 TUBE; 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(58133-210)
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