Label: LIDOCAINE HCL 4 PERCENT- lidocaine hydrochloride cream

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

Drug Label Information

Updated April 30, 2024

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  • SPL UNCLASSIFIED SECTION

    LIDOCAINE - Lidocaine HCl 4% Cream
    AriBrands, LLC 

    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.

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  • Lidocaine HCl 4% Topical Analgesic Cream

    ​Drug Facts

  • Active ingredient

    Lidocaine HCl 4% w/w

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves pain and itching due to:

    • minor cuts
    • sunburn
    • minor scrapes
    • minor burns
    • insect bites
    • minor skin irritations
  • Warnings

    ​For external use only.

    When using this product

    • Avoid contact with the eyes
    • Do not use in large quantities, particularly over raw surfaces or blistered areas

    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.
    • If allergic reaction occurs or if redness, irritation, swelling, pain or other symptoms begin or increase.

    Keep out of reach of children.

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

  • Directions

     adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
     children under 2 years ask a doctor
  • Other information

    • May be applied under occlusive dressing.
    • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.
  • Inactive ingredients

    Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    Lidocaine HCl 4% cream

    NDC 71436-0026-1 

    Topical Analgesic Cream

    4.2 OZ (120 g)

    AriBrands, LLC

    PRINCIPAL DISPLAY PANEL Lidocaine HCl 4% cream NDC 71436-0026-1 Topical Analgesic Cream 4.2 OZ (120 g) AriBrands, LLC

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HCL 4 PERCENT 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71436-0026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71436-0026-1120 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2024
    Labeler - ARI BRANDS, LLC (080658382)
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