Active Ingredient
Phenylephrine HCI 0.25%
Witch Hazel 50%
Hemorroidal Cooling Gel
FDA Label NDC 69396-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Hemorroidal Cooling Gel (NDC 69396-032). 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, stop use and ask a doctor, if pregnant or breast feeding, keep out of the reach of children, directions, warnings, 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
- temporarily relief of irritation and burning
- temporarily shrinks hemorrhoidal tissue
- aids in protecting irritated anorectal areas
Stop Use And Ask A Doctor
- bleeding occurs
- condition worsens or does not improve within 7 days
- introduction of applicator into the rectum causes additional pain
If Pregnant Or Breast Feeding
Ask a doctor before use
Keep Out Of The Reach Of Children
If swallowed get medical help or contact Poison Control Center right away
Directions
Children under 12 years of age; ask a doctor before use
Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe
- gently dry by patting or blotting with a tissue or soft cloth before applying
- when first opening tube, remove foil seal
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
Warnings
For External Use Only
Ask doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty urinating due to an enlarged prostate gland
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Ask doctor before use if you are presently taking a prescription drug for high blood pressure or depression.
When using this product
Other Information
Store at room temperature 20°-25°C (68°-77°F)
Do not use if tube seal under cap is broken or missing
** This product is not manufactured or distributed by Wyeth Consumer Healthcare Inc. owner of the registered trademark Preparation H®
Inactive Ingredients
Aloe barbadensis gel, benzophenone-4, Acetate disodium, Hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, Vitamin E, water
Questions Or Comments
Call Toll Free 1-888-296-9067
Distributed By
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301, USA
1-888-296-9067
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