Label: HEMORRHOIDAL RELIEF CREAM- lidocane cream

  • Category: HUMAN OTC DRUG LABEL

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 June 25, 2020

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  • INDICATIONS & USAGE

    Uses

    Temporarily relieves pain, itching and discomfort due to anorectal disorders and temporarily shrinks hemorrhoidal tissue.

  • WARNINGS

    Warnings

    For External use only

    Allergy alert: Certain persons can develop allergic reactions to ingredients in this product

  • 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.
  • INFORMATION FOR PATIENTS

    Other information

    • To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
    • Tamper-Evident: do not use if foil seal under cap is broken or missing.
    • See crimp of tube for lot number and expiration date.
  • 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

    Active Ingredients Purpose

    Lidocaine 5%...............................Local anesthetic

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

  • ASK DOCTOR

    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

  • STOP USE

    Stop use and ask a doctor if

    Rectal 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

  • ASK DOCTOR/PHARMACIST

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


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

  • WHEN USING

    When using this product

    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 doct

  • PRINCIPAL DISPLAY PANEL

    box front panel

    box side panel abox back panelbox side panel b

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL RELIEF CREAM 
    lidocane cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-982
    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:69842-982-011 in 1 BOX05/01/2017
    1NDC:69842-982-0228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/13/2010
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.805617610manufacture(69842-982)
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