FDA Label for Lidocaine 5 Percent
View Indications, Usage & Precautions
Lidocaine 5 Percent Product Label
The following document was submitted to the FDA by the labeler of this product Alexso, Inc. 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
Topical anesthetic
Uses
For the temporary relief of local pain, soreness, burning, itching or discomfort associated with anorectal disorders.
Warnings
For external use only.
When Using This Product
- avoid contact with eyes
- do not exceed recommended daily dosage unless directed by a physician
- do not put this product into the rectum by using fingers or any mechanical device or applicator
- in case of bleeding, consult a physician promptly
Stop Use And Ask A Physician If
- allergic reaction occurs
- condition worsens or does not improve within 7 days
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- symptoms clear up and return within a few days
- if pregnant or breastfeeding
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 a soft cloth before application of this product.
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 physician.
Other Information
- May be applied under occlusive dressing.
- Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
Inactive Ingredients
Aloe Barbadensis Leaf (Aloe Vera Juice), Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativus (Hemp) Seed Oil, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Yerba Mate) Extract, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Magnesium Sulfate, Phenoxyethanol, Polyacrylamide, Stearic Acid.
Principal Display Panel
Lidocaine 5% Cream
NDC 50488-6265-1
Lidocaine 5%
Anorectal Cream
Topical Anesthetic
50 grams
Manufactured for:
Alexso, Inc.
Los Angeles, CA 90064
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