Label: HEMAWAY- lidocaine cream

  • NDC Code(s): 54473-336-02, 54473-336-31
  • Packager: Melaleuca, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2025

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  • INDICATIONS & USAGE

    Uses

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

  • 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 and 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.
  • QUESTIONS

    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

    Lidocaine 5%

  • PURPOSE

    Local anesthetic

  • 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
    • Conditions worsens or does not improve within 7 days
    • Allergic reaction occurs
    • Symptoms clear up and return in a few days
    • Redness, irritation, swelling, pain or other symptoms begin or increase
  • ASK DOCTOR/PHARMACIST

    Ask a Doctor or Pharmacist if you are: Presently taking a prescription drug for high blood pressure or depression.

  • PREGNANCY OR BREAST FEEDING

    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 doctor.
  • PRINCIPAL DISPLAY PANEL

    HemAway MaxStrength Box.jpg

    HenAway MaxStregnth Tube.jpg

  • INGREDIENTS AND APPEARANCE
    HEMAWAY 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1.5 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-336-021 in 1 BOX08/04/2020
    1NDC:54473-336-3130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01508/04/2020
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.805617610manufacture(54473-336)
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