Label: DR REAL NUMB TOPICAL ANORECTAL- lidocaine cream

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

Drug Label Information

Updated November 9, 2023

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  • Drug Facts

  • Active ingredient

    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 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 sympton 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 an appropriate cleansing pad.
    • 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.
  • Ingredients:

    Aqua (deionized water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Benzyl Alochol, Butylene Glycol, Chamomilla Matricaria (Chamomile) Extract, Ethylhexylglycyerin, Glycerin, Phenoxyethanol, Tetrasodium EDTA, Thymus Vulgaris (Thyme) Extract, Zemea (corn) Propanediol.

  • Other information:

    • Protect the product in this container from excessive heat and direct sun.
    • Store at 20-25°C (68-77°F) and protect from moisture.
  • Question?

    Call + 8614774822118

    E-mail: customerservice@drrealnumbcream.com

  • Package Labeling:

    Label00

  • INGREDIENTS AND APPEARANCE
    DR REAL NUMB TOPICAL ANORECTAL 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83800-430
    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
    WATER (UNII: 059QF0KO0R)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    THYME (UNII: CW657OBU4N)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83800-430-001 in 1 BOX11/03/2023
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01511/03/2023
    Labeler - FUZZYLULU LLC (119082660)
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