Active Ingredients
Lidocaine 5% w/w
Lidocaine 5% Topical Anorectal Cream
FDA Label NDC 73715-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mohnark Pharmaceuticals Inc. for the product Lidocaine 5% Topical Anorectal Cream (NDC 73715-002). 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 ingredients, purpose, warnings, when using this product, stop use and ask doctor if, keep out of reach of children, directions, other information, 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 relieves pain, itching and burning associated with hemorrhoids and other anorectal disorders
Warnings
For external use only
When Using This Product
- 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 Doctor If
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- symptoms clear up and return in a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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 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.
Other Information
- Store at USP controlled room temperature 20-25 oC (68-77 oF).
Inactive Ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.
Dosage
50 milligrams/gram per application
Usage
- Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
- Children under 2 years of age: consult a doctor
Package Label
5% Lidocaine Cream (5carton)
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