TEDS TOPICAL PAIN GEL ROLL ON (TROLAMINE SALICYLATE 10%) GEL [COSMETIC SPECIALTY LABS, INC.]

TEDS TOPICAL PAIN GEL ROLL ON (TROLAMINE SALICYLATE 10%) GEL [COSMETIC SPECIALTY LABS, INC.]
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NDC 58133-211-03
Set ID 84af0590-db35-2b23-e053-2a91aa0a89c0
Category HUMAN OTC DRUG LABEL
Packager Cosmetic Specialty Labs, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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