FDA Label for Anorectal
View Indications, Usage & Precautions
Anorectal Product Label
The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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 Purpose
Lidocaine 5%........................................Local Anesthetic
Uses
For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.
Warnings For External Use Only.
When using this product • do not get into eyes. • do not exceed the recommended daily 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 • condition worsens or does not improve within 7 days. • in case of bleeding, consult a doctor promptly • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
If pregnant or breastfeeding, ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get help or contact a Poison Control Center right away.
Directions
Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement • Children under 12 years of age: consult a doctor.
Other Information
Store at 25° C (77°F); excursions permitted to 15-30° C (59-86° F).
Inactive Ingredients
Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water,
Trolamine, Vitamin E Acetate.
Questions?
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