Label: HEMAWAY - lidocaine and phenylephrine hydrochloride cream 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/10

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Uses

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

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  • WARNINGS

    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
    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 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.

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

    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

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  • 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.
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  • 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.
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  • 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

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  • ACTIVE INGREDIENT

    Active Ingredients                              Purpose
    Lidocaine 5%...............................Local anesthetic
    Phenylephrine HCI.........................Vasoconstrictor

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    HEMAWAY 
    lidocane and phenylephrine hcl cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54473-180
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (LIDOCAINE) LIDOCAINE 50 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    Benzyl Alcohol  
    CARBOMER HOMOPOLYMER TYPE C  
    CHOLESTEROL  
    HYDROGENATED SOYBEAN LECITHIN  
    ISOPROPYL MYRISTATE  
    POLYSORBATE 80  
    Propylene Glycol  
    Water  
    Trolamine  
    ALPHA-TOCOPHEROL ACETATE  
    GRAPE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-180-01 1 in 1 BOX
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 12/13/2010
    Labeler - Melaleuca, Inc. (139760102)
    Registrant - Melaleuca, Inc. (139760102)
    Establishment
    Name Address ID/FEI Business Operations
    Melaleuca, Inc. 805617610 manufacture(54473-180)
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