Label: LIDOCAINE PLUS MAXIMUM STRENGTH PAIN RELIEVING CREAM- lidocaine hydrochloride cream

  • NDC Code(s): 58443-0123-3
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL

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Updated July 15, 2020

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  • Active Ingredients

    Lidocaine Hydrochloride 4%

  • Purpose

    Pain Relieving Cream

  • Indications (Uses)

    For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

  • WARNINGS

    For external use only.

    Avoid contact with the eyes.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

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

    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 of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Consult a doctor.
    • Always tighten cap firmly after each use
  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

  • Other Information

    Questions or Comments?

    Call 1-888-263-9808

  • Lidocaine Plus Maximum Strength Pain Relieving Cream

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PLUS  MAXIMUM STRENGTH PAIN RELIEVING CREAM
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS39.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURETH-7 (UNII: Z95S6G8201)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0123-3118 mL in 1 TUBE; Type 0: Not a Combination Product03/02/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/02/2007
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0123) , manufacture(58443-0123) , label(58443-0123) , analysis(58443-0123)
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