Active Ingredient
Lidocaine 4%
Xesso Strawberry Rear Comfort Glide 4% Lidocaine Gel
FDA Label NDC 81777-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Premium Natural Cosmetics Inc for the product Xesso Strawberry Rear Comfort Glide 4% Lidocaine (NDC 81777-105). 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, ask a doctor section, purpose, use, keep out of reach of children, stop use, directions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask A Doctor Section
As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
Purpose
Anorectal
Use
For temporary relief of pain, soreness, or burning in the perianal area.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
Stop Use
Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
Directions
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad. 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 daily.
Warnings
Warnings:
• For external use only. Do not use this product with a mechanical device.
• 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.
• Do not exceed the daily recommended dosage.
• Do not apply onto cracked or broken skin.
• In case of any bleeding, discontinue use and consult a doctor.
Other Information
Other Information:
• Store at room temperature 20 - 25°C (68 - 77°F).
• Do not use if tamper evident seal on the outside of the container is broken or missing.
Inactive Ingredients
Inactive Ingredients: Carboxymethylcellulose Sodium, Diazolidinyl urea, Glycerin, Isopentyldiol, Methylparaben, Propylparaben, Water, Natural Flavor.
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