TEDS TOPICAL PAIN CREAM (METHYL SALICYLATE 10%) CREAM [COSMETIC SPECIALTY LABS, INC.]

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TEDS TOPICAL PAIN CREAM (METHYL SALICYLATE 10%) CREAM [COSMETIC SPECIALTY LABS, INC.]
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NDC 58133-210-03
Set ID 849d6e28-a6c1-7f49-e053-2a91aa0a497d
Category HUMAN OTC DRUG LABEL
Packager Cosmetic Specialty Labs, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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