Active Ingredient
Lidocaine 4%
Xesso Rear Comfort Glide Gel
FDA Label NDC 81777-101
12 label sections · Submitted to the FDA by Premium Natural Cosmetics Inc · 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 Rear Comfort Glide (NDC 81777-101). 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, do not use, keep out of reach of children, purpose section, stop use, pregnancy or breast feeding section, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask A Doctor Section
Ask a health professional before using this product.
Do Not Use
- Do not exceed the daily recommended dosage.
- Do not apply onto cracked or broken skin.
- In case of bleeding, discontinue use and consult a doctor.
Keep Out Of Reach Of Children
In case of accidental overdose, seek medical help or call a Poison Control Center right away.
Purpose Section
Anorectal
Stop Use
Certain persons can develop allergic reactions to ingredients in this product, If the symptoms being treated does not subside or if redness, irritaition, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
In case of any bleeding, discontinue use and consult a doctor.
Pregnancy Or Breast Feeding Section
As with any drug, consult a health care professional if you are pregnant or nursing.
Inactive Ingredients
Carboxymethylcellulose sodium, diazolidinyl urea, glycerin, isopentyldiol, methylparaben, propylparaben, water
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.
Use
For temporary relief of pain, soreness or burning in the perianal area.
Other Information
- Store at room temperature 20 - 25 C (68 - 77F)
- Do not use if tamper evident seal on the outside of the container is broken or missing.
Package Label.Principal Display Panel
Xesso Black
Rear Comfort Glide
Slippery and Mild Numbing
Thick, Water-Based Formula
PEG-Free and Oil-Free
8.3 fl oz | 245 mL
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