PAIN RELIEF CREAM (TROLAMINE SALICYLATE) CREAM [ALLURE LABS INC.]

PAIN RELIEF CREAM (TROLAMINE SALICYLATE) CREAM [ALLURE LABS INC.]
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NDC 62742-4091-1
Set ID b3ac69c7-5df7-4f47-a3a7-8461892b4276
Category HUMAN OTC DRUG LABEL
Packager ALLURE LABS INC.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredients:

    Trolamine Salicylate - 10%

  • PURPOSE

    Purpose:

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises. 

  • WARNINGS

    For external use only.

  • ASK DOCTOR

    Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate.

  • WHEN USING

    When using this product: Avoid contact with eyes or mucous membranes; if contacts occurs, flush with water for 15 minutes. Do not apply to wounds or damaged skin.

  • STOP USE

    If pain persist more than 7 days or redness or irritation is present or in condition affecting children under 12 years of age, consult a physician immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acetyl Glucosamine, Butylene Glycol, Capriylic/ Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol,Cyclopentasilaxane, Dimethicone, Dimethyl Sulfone (MSM), Disodium EDTA, Fragrance, Glyceryl Stearate, Imidazolidinyl Uraea, Isopropyl Palmitate, Lecithine, PEG-100 Stearate, Phenoxy ethanol, Potassium Sorbitate, Tocopheryl Acetate, Vanillyl Butyl Ethar, Water, Xanthan Gum. 

  • DOSAGE & ADMINISTRATION

    Contains Gradual Heating Sensation. Adults and Children 12 years of age and older: use no more than 3-4 times daily. Before Activity-Massage onto muscles and joints 10-30 minutes before to warm up. After - Apply cream to sore or injured areas immediately after activity or after showering. Wash hands thoroughly with soap and water after use

  • PRINCIPAL DISPLAY PANEL

    Distributed by:

    Flex Power Inc.

    Berkeley, CA 94710Image FlxPower40.jpg

    Image FlxPower20.jpg

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM ACETYL GLUCOSAMINE PHOSPHATE (UNII: SC89MF712W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETEARETH-2 (UNII: ATB309OMWW)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    N-(1,3-BIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA (UNII: N9VX1IBW6K)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4091-157 g in 1 TUBE; Type 0: Not a Combination Product11/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/27/2017
    Labeler - ALLURE LABS INC. (926831603)
    Registrant - ALLURE LABS INC. (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALLURE LABS INC.926831603manufacture(62742-4091)

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