Label: SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF- lidocaine cream

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

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active ingredient

    Lidocaine 5.00 %

    Purpose

    Anorectal (hemorrhoidal)

  • Uses:

    • For the temporary relief of itching and discomfort in the perianal area.
    • For the temporary relief of pain, soreness, or burning.
  • Warnings:

    For external use only.

    Do not

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

    When using this product

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

    Discontinue use and consult a doctor if

    • The symptoms being treated does not subside.
    • Redness, irritation, swelling, pain, or other symptoms develop or increase.
    • Certain persions can develop allergic reactions to ingredients in this product.

    Allergy alert

    Keep out of reach of children.

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

    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 thoroughly.

    • 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 to the affected area up to 6 times daily.

  • Other information:

    • Store at 20-25°C (68-77°F) and protect from moisture.
  • Inactive ingredients:

    Allantoin, Deionized Water, Benzyl Alcohol, Carbomer, Propylene Glycol, SD Alcohol 40-B, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E).

  • Questions?

    +1 (205) 624-9177

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82460-262
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82460-262-0030 mL in 1 TUBE; Type 0: Not a Combination Product01/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/09/2022
    Labeler - ALPHA PLANTS INC (118246522)
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