Label: HEMORRHOIDAL RELIEF CREAM- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 27, 2023

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  • INDICATIONS & USAGE

    Uses

    Temporarily relieves pain, itching and discomfort due to anorectal disorders.

  • WARNINGS

    For External Use Only

    Allergy Alert- Certain persons can develop allergic reactions to ingredients in this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

    When using this product

    • avoid contact with eyes
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
    • do not exceed the recommended daily dosage unless directed by a doctor

    Stop use and ask a doctor if

    • retal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain, or other symptoms begin or increase

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults: when practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
    • Children under 12 years of age: consult a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients: Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

  • ACTIVE INGREDIENT

  • OTHER SAFETY INFORMATION

    • Store at 20-25 0C (68-77 oF)
    • to secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
  • QUESTIONS

    Questions & Comments? 516-444-5749

  • PURPOSE

    Local Anesthetic

  • PRINCIPAL DISPLAY PANEL

    BoxTube

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL RELIEF CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0468
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GRAPE (UNII: 6X543N684K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0468-11 in 1 BOX09/01/201903/31/2023
    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 finalpart34608/15/201903/31/2023
    Labeler - Cardinal Health (063997360)
    Registrant - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.805617610manufacture(70000-0468)
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