Indications & Usage
Uses
Temporarily relieves pain, itching and discomfort due to anorectal disorders.
Hemaway Cream
FDA Label NDC 54473-336
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 54473-336). 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, otc - questions, inactive ingredient, otc - active ingredient, otc - purpose, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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
Otc - Active Ingredient
Active Ingredients
Lidocaine 5%
Otc - Purpose
Local anesthetic
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.
Otc - 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
Otc - 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
Otc - Ask Doctor/Pharmacist
Ask a Doctor or Pharmacist if you are: Presently taking a prescription drug for high blood pressure or depression.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding ask a health professional before use.
Otc - 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.
* Please review the disclaimer below.
