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FDA LABEL MFR: Melaleuca, Inc.

Hemaway (lidocaine 5 % / Phenylephrine Hydrochloride 0.25 % ) Rectal Cream

INDICATIONS AND 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 AND 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.

PATIENT COUNSELING INFORMATION

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

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

ASK A DOCTOR