Label: PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE- lidocaine cream

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

Drug Label Information

Updated April 11, 2024

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  • Drug Facts

  • Active ingredients

    Lidocaine 5.00 %

    Purpose

    Anorectal (hemorrhoidal)

  • Uses

    • Helps relieve the local itching and discomfort in the perianal area 
    • For the temporary relief of pain, irritation” or burning.
  • Warnings:

    For external use only

    Do not

    • exceed the recommended daily dosage unless directed by a doctor. 
    • put this product into the rectum by using fingers or any mechanical device or applicator.

    When using this product

    • If the condition worsens or does not improve within 7 days, consult a doctor. 
    • In case of bleeding, consult a doctor promptly.

    Stop use and ask a doctor if

    • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

    Allergy alert 

    • Certain persons can develop allergic reactions to ingredients in this product.

    Keep out of reach of children.

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

    If pregnant or breast-feeding,

    ask a health professional before use

  • Directions:

    Adults:

    • When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad 
    • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
    • Children under 12 years of age: consult a doctor. 
    • Apply externally to the affected area up to 6 times daily or after each bowel movement.
  • Other information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Ethylhexylglycerin, Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6

  • Questions?

    call toll-free 1-800-630-8895

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-813-06170 g in 1 TUBE; Type 0: Not a Combination Product04/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/22/2024
    Labeler - Advanced Rx LLC (042795108)
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