Active Ingredient
Glycerol 14.4%
Phenylephrine HCI 0.25%
Pramoxine HCI 1%
White Petrolatum 15%
Hemorrhoidal Cream
FDA Label NDC 69396-171
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 Hemorrhoidal Cream (NDC 69396-171). 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 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
Protectant
Vasoconstrictor
Local Anesthetic
Protectant
Uses
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
Temporary relief of pain, soreness and burning
Stop Use And Ask A Doctor
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
If Pregnant Or Breast Feeding
Ask doctor 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, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.
When first opening tube remove 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 applicator. Attach applicator to tube. Lubricate applicator well then gently insert applicator pathway into the anus.
Thoroughly clense applicator after each use and replace cover.
Children under 12 years of age, ask a doctor.
Warnings
For External Use Only
Ask doctor brfore use if you have
Heart Disease
Thyroid Disease
Diabetes
thyroid disease
Difficulty urinating due to enlargement of prostate gland
Ask doctor before use if you arepresently taking a prescription 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 into the rectum by using fingers or any mechanical device or applicator
Other Information
Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetearyl alcohol, mono and di glycerides, methylparaben, light mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum
Questions Or Comments
Call 1-888-296-9067
Distributed By
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301, USA
1-888-296-9067
www.trifecta-pharma.com
SKU: 430903-FBA
This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H.
Do not use if tube seal under cap is broken or missing.
* Please review the disclaimer below.
