Hemaway
FDA Label NDC 54473-180

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Hemaway (NDC 54473-180). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage, warnings, dosage & administration, information for patients, inactive ingredient, otc - active ingredient, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

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

Otc - Active Ingredient

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

Otc - 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.

Package Label.Principal Display Panel

Image Of Box (Haboxlabel)

Image Of Box (Haboxlabel)

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