Active Ingredient
Lidocaine 5% W/W
Medpride Relief Cream
FDA Label NDC 52410-1090
13 label sections · Submitted to the FDA by Shield Line Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Line Llc for the product Medpride Relief (NDC 52410-1090). 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, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children and pets., 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, itching, and burning, associated with hemorrhoids and anorectal disorders.
Warnings
For external use only
When Using This Product
- use only as directed
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- symptoms clear up and occur again within a few days
- an allergic reaction develops to ingredients in this product
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adult and children 12 years and over:
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
- apply externally to the affected area up to 6 times a day
children under 12 years of age: consult a doctor.
Other Information
Store between 15°-30° C (59°-30° F)
Inactive Ingredients
Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin (Soya), Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate
Questions
1-888-277-6533
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