TED S PAIN (METHYL SALICYLATE) CREAM [CERSCI THEREPEUTICS, INC.]

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TED S PAIN (METHYL SALICYLATE) CREAM [CERSCI THEREPEUTICS, INC.]
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NDC 70336-718-01
Set ID 54ecfc52-8c81-422f-b3b1-5538ac3d9687
Category HUMAN OTC DRUG LABEL
Packager Cersci Therepeutics, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active ingredients:

    Methyl Salicylate 10%

    Purpose

    Topical Pain Relief

  • Uses

    For the temporary 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 ues

    • 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

    • avoid contact with eyes and mucus membranes • do not bardage 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 occur • pregnant or breastfeeding.

    Keep out of reach of 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 to 4 times daily • children under 2 years of age: consult a physician.

  • Other Information

    Store at 20°C to 25°C (68°F - 77°F).

  • 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:

    label

  • INGREDIENTS AND APPEARANCE
    TED S PAIN 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70336-718
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    RESVERATROL (UNII: Q369O8926L)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70336-718-011 in 1 CARTON02/09/2017
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/14/2015
    Labeler - Cersci Therepeutics, Inc. (079742216)
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