Label: NEUROMED 7 TOPICAL PAIN RELIEF - lidocaine hydrochloride cream 

  • Label RSS
  • NDC Code(s): 54723-175-22
  • Packager: Sambria Pharmaceuticals, LLC
  • 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 08/13

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  • NeuroMed 7 Topical Pain Relief Cream
  • Active Ingredients

    Lidocaine HCl (4.00%)

    Purpose

    External Anesthetic

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  • Uses:

    For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburn and minor burns. Also used for temporary relief of itching associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak and poison sumac, soaps, detergents, cosmetics and jewelry.

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  • Warnings:

    - For external use only.

    - Avoid contact with eyes.

    - If symptoms persists for more than seven days, or clear up and occur again within a few days, discontinue use and consult physician.

    - If redness, irritation, swelling, pain or other symptoms increase, discontinue and consult a physician.

    Keep out of reach of children.

    If swallowed, consult physician.

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  • Directions:

    For adults and children two-years or older, apply externally to the affected area. Do not use more than three or four times per day.

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  • Other ingredients:

    Aqua (Deionized Water), Arnica Montana Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonyl Methane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

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  • NeuroMed 7 Topical Pain Relief Cream 2.2oz/63g (54723-175-22)
  • INGREDIENTS AND APPEARANCE
    NEUROMED 7 TOPICAL PAIN RELIEF 
    lidocaine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54723-175
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ARNICA MONTANA  
    C13-14 ISOPARAFFIN  
    CHONDROITIN SULFATE (BOVINE)  
    EMU OIL  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    ETHYLHEXYLGLYCERIN  
    GLUCOSAMINE SULFATE  
    ISOPROPYL PALMITATE  
    LAURETH-7  
    DIMETHYL SULFONE  
    PHENOXYETHANOL  
    PROPYLENE GLYCOL  
    STEARIC ACID  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54723-175-22 1 in 1 CARTON
    1 63 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/15/2013
    Labeler - Sambria Pharmaceuticals, LLC (078676259)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source Inc. 969241041 manufacture(54723-175)
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