FDA Label for Hemorrhoidal Relief Cream
View Indications, Usage & Precautions
Hemorrhoidal Relief Cream Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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.
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
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
Otc - Ask Doctor/Pharmacist
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.
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 doct
* Please review the disclaimer below.