FDA Label for Rectaease Hemorrhoid Relief Cream
View Indications, Usage & Precautions
Rectaease Hemorrhoid Relief Cream Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 5% w/w
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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