Label: NUMBR-X- lidocaine hcl cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 19, 2024

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

  • Active Ingredient

    Lidocaine HCL 4%

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations

  • Warnings

    • For external use only.
    • Avoid contact with eyes

    Stop use and ask a doctor if

    • Condition worsens or symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
    • Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

    Do not use

    • On wounds or damaged skin.
  • Keep out of reach of children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Direction

    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: do not use, consult a physician.

  • Other information

    Do not use if seal is broken.

  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

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  • Product label

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  • INGREDIENTS AND APPEARANCE
    NUMBR-X 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70171-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ELOSULFASE ALFA (UNII: ODJ69JZG85)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EMU OIL (UNII: 344821WD61)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70171-0001-11 in 1 CARTON07/18/2024
    128 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/18/2024
    Labeler - Prodigy Media Inc (080011622)