Active Ingredient
- Phenylephrine HCI, 0.25%
- Witch Hazel, 50.0%
Drs. Pharmacy Hemorrhoidal Cooling Gel
FDA Label NDC 80489-959
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ol Pharma Tech, Llc Drs Pharmacy for the product Drs. Pharmacy Hemorrhoidal Cooling (NDC 80489-959). 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 ingredient, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop using and ask your doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- 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
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
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking a prescription drug for high blood pressure or depression
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
Stop Using And Ask Your Doctor If
- bleeding occurs
- condition worsens or does not improve within 7 days
If Pregnent 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.
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, puncture foil seal with top end of cap
- 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
edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite
Questions
www.drspharmacyusa.com
Package Label.Principal Display Panel
Hemorroidal Cooling Gel (Img 3702)
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