Label: NEUROMED 7 TOPICAL PAIN RELIEF- lidocaine hydrochloride cream

  • NDC Code(s): 54723-175-22
  • Packager: Sambria Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 1, 2016

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

  • Active Ingredients

    Lidocaine HCL 4.0% w/w

    Purpose

    External Anesthetic

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  • Uses

    For temporary relief of pain and itching due to minor skin irritation.

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  • Warnings

    - For external use only.

    - Avoid contact with eyes.

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  • DO NOT USE

    - ​Do not use ​in large quantities, particularly over raw surfaces or blistered areas.

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  • STOP USE

    - ​Stop use and ask a doctor ​if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.  Discontinue use.

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  • KEEP OUT OF REACH OF CHILDREN

    - ​Keep out of reach of children.​  If product is swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.

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  • ​Inactive Ingredients

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

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  • ​Other Information

    Protect this product from excessive heat and direct sun.

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  • ​Questions or Comments?

    FDA Registered: NDC No 54723-175-22

    info@sambriapharma.com

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  • INGREDIENTS AND APPEARANCE
    NEUROMED 7 TOPICAL PAIN RELIEF 
    lidocaine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-175
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    EMU OIL (UNII: 344821WD61)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54723-175-22 1 in 1 CARTON 04/13/2016
    1 63 g in 1 TUBE; Type 0: Not a Combination Product
    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
    A.I.G. Technologies, Inc. 171837367 manufacture(54723-175)
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