Label: HEMAWAY- lidocaine cream

  • NDC Code(s): 54473-336-01, 54473-336-30
  • Packager: Melaleuca, Inc.
  • 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 11, 2023

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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

    TubeBox

  • 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
    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:54473-336-011 in 1 BOX08/04/2020
    1NDC:54473-336-3030 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/04/2020
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.805617610manufacture(54473-336)
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