FDA Label for Hemorrhoidal Pain Relief Cream
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Hemorrhoidal Pain Relief Cream Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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.
Otc - Active Ingredient
Active ingredients
Glycerin 14.4%
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
White petrolatum 15%
Otc - Purpose
Purposes
Protectant
Vasoconstrictor
Local anesthetic
Protectant
Indications & Usage
Uses
• for temporary relief of pain, soreness and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings
For external use only
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
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 - When Using
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
- an allergic reaction develops
- the symptom being treated does not subside or if redness, irritation, swelling, pain or
- other symptoms develop or increase
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222).
Dosage & Administration
Directions
- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
- when first opening the tube, peel off the foil seal
- apply externally or in the lower portion of the anal canal only
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
- thoroughly cleanse dispensing cap after each use and replace cover
- children under 12 years of age: ask a doctor
Other Safety Information
Other information
- store at 20-25 °C (68-77 °F)
Inactive Ingredient
Inactive ingredients aloe barbadensis leaf extract, butylated hydroxy anisole, cetostearyl alcohol, cetyl ester wax, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, vitamin E acetate
Otc - Questions
Questions or comments?
Call 1-877-290-4008
Package Label.Principal Display Panel
* Please review the disclaimer below.