Active Ingredients
Phenylephrine HCl 0.25%
Witch hazel 50.0%
Hemorrhoidal Cooling Gel
FDA Label NDC 0363-9712
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Hemorrhoidal Cooling Gel (NDC 0363-9712). 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 active ingredients, purposes, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Vasoconstrictor
Astringent
Uses
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporary relief of irritation and burning
- temporarily shrinks hemorrhoidal tissue
- aids in protecting irritated anorectal areas
Warnings
For external use only
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 - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug
for high blood pressure or depression.
Otc - When Using
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product into the 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
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).
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 gel.
- when first opening the tube, peel off the foil seal
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- children under 12 years of age: ask a doctor
Other Information
- store at 20-25°C (68-77°F)
Inactive Ingredients
aloe barbadensis leaf extract, edetate disodium,hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol,propylparaben,purified water, sodium citrate, sulisobenzone, vitamin E acetate
Questions Or Comments?
Call 1-877-290-4008
* Please review the disclaimer below.
