Active Ingredient
Lidocaine 5% w/w
Rectoprotect Cream
FDA Label NDC 71399-0050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Rectoprotect (NDC 71399-0050). 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, directions, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children. if swallowed, get medical help or contact a poison control center right away., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
Uses
temporarily relieves pain and itching due to anorectal disorders
Directions
- when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth
- before applying.
- adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
- children under 12 years of age: Consult a doctor
Warnings
When Using This Product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
Stop Use And Ask A Doctor If
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs
- redness, irritation, swelling, pain or other symptoms begin or increase
- symptoms clear up and return within a few days
Keep Out Of Reach Of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.
Other Information
- May be applied under occlusive dressing.
- Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients
Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purifed Water, Trolamine and Vitamin E Acetate.
Questions Or Comments?
Call toll-free 1-877-255-6999
Manufactured for:
Akron Pharma Inc.
Fairfield, Nj 07004
www.akronpharma.com
Package Label.Principal Display Panel
5-15-1 (Lidocaine5 15g Page 1)
5-15-2 (Lidocaine5 15g Page 2)
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