Active Ingredient
Lidocaine 5% w/w
Rectaease Hemorrhoid Relief Cream
FDA Label NDC 69396-070
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 Rectaease Hemorrhoid Relief Cream (NDC 69396-070). 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, warning section, stop use and ask a doctor, when using this product, if pregnant or breast feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Uses
Helps relieve the pain, ithcing and burning associated with hemorrhoids and other anorectal disorders.
Warning Section
For External Use Only
Stop Use And Ask A Doctor
Rectal bleeding occurs
Condition worsens
Symptoms persist for more than 7 days or clear up and return within a few days
Symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
When Using This Product
Avoid contact with the eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator
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
Directions:
When practical, clean the affected area with mild soaping warm water and rinse thoroughly.
Gently dry by patting or blotting with a toilet tissue or soft cloth before applying.
Adult and children 12 years of age and older, apply to affected area not more than 6 times a day.
Children under 12 years of age: do not use, ask a doctor
To use finger cots: Roll one cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Other Information
Store at 20°-25°C (68°-77°F)
Inactive Ingredients
Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl myristate, Propylene glycol,Trolamine, Vitamin E, polysorbate 80, propylene glycol, purified water
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
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