Label: BAKERS BEST ARTHRITIS PAIN RELIEF - methyl salicylate, menthol and lidocaine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts
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  • ACTIVE INGREDIENT

    Active Ingredients: Methyl Salicylate (4.50%), Menthol (2.50%), Lidocaine HCl (1.00%).

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  • PURPOSE


    Purpose: Pain Relief
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  • INACTIVE INGREDIENT

    Inactive Ingredients: Deionized Water, Aloe Vera Gel, Cetyl Alcohol, PEG-8, Isopropyl Myristate, Emu Oil, MSM, Glucosamine Sulfate, Polyacrylamide, C13-14 Isoparaffin, Laurenth-7, Propylene Glycol, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, Acrylates/C10-13 Alkyl Acrylate, Triethanolamine, Polysorbate-80.

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  • INDICATIONS & USAGE

    Uses: For temporary relief of minor aches and pains of muscles and joints associated with arthritis, sprains, and simple backaches.

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  • WARNINGS

    Warnings:

    • For external use only.
    • Avoid contact with eyes, mucous membranes and broken or irritated skin.
    • In case of accidental contact, flush with water.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.
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  • WHEN USING

    • If irritation occurs, discontinue use immediately.
    • Do not tightly wrap or bandage or use with other topical preparations or heating pads.
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  • ASK DOCTOR

    • Consult a doctor if you are pregnant/nursing, under 12 years old, have sensitive skin, your condition persists or worsens, or excessive burning or irritation persists.
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  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and over, apply product directly to affected areas and gently rub until it's fully absorbed. Product may be used as necessary, but should not be used more than 3-4 times daily.

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  • SPL UNCLASSIFIED SECTION

    Other Information:

    • Use only as directed
    • Store at room temperature
    lot/exp:

    Distributed by: Baker's Best Health Products, Inc.
    P.O. Box 2099, Wixom, MI 48393
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  • PRINCIPAL DISPLAY PANEL

    Baker's Best

    Arthritis Pain Relief Cream

    Net Wt. 2oz (56.7g)

    To reorder, call 1-800-720-0099 or visit www.bakersbesthealth.com



    BakersBestCream

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  • INGREDIENTS AND APPEARANCE
    BAKERS BEST ARTHRITIS PAIN RELIEF 
    methyl salicylate, menthol, lidocaine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76102-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 4.5 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL 2.5 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALOE VERA LEAF  
    CETYL ALCOHOL  
    POLYETHYLENE GLYCOL 400  
    ISOPROPYL MYRISTATE  
    EMU OIL  
    DIMETHYL SULFONE  
    GLUCOSAMINE SULFATE  
    C13-14 ISOPARAFFIN  
    LAURETH-7  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    DIAZOLIDINYL UREA  
    TROLAMINE  
    POLYSORBATE 80  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76102-100-02 56.7 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/10/2011
    Labeler - Baker's Best (967388476)
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