Active Ingredient
Lidocaine 5%
Lubricaine 5 Gel
FDA Label NDC 63135-924
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Esba Laboratories Inc. for the product Lubricaine 5 (NDC 63135-924). 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, purpose, warnings, uses, when using this product, stop use and ask a doctor if, keep out of the reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anorectal Anesthetic
Warnings
For external use only.
Uses
For temporary relief of pain, soreness or burning in the perianal area
When Using This Product
Do not use this product with a mechanical device. Certain persons can develop allergic reactions to ingredients in this product.
Stop Use And Ask A Doctor If
- 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.
- In case of bleeding, consult a doctor promptly.
- As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
- Apply externally to the affected area up to 6 times daily.
Other Information
- Store at room temperature 20-25oC (68-77oF).
- Tamper Evident: do not use if seal under cap is broken or missing.
- Child-Resistant Cap: push down and turn to open.
Inactive Ingredients
Allantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.
Questions
Call toll-free in USA & Canada 800-677-9299 9 am -5 pm Eastern Time M-F or visit www.esbalabs.com.
Package Label.Principal Display Panel
Label Of Tube Of Lubricaine (Lidocaine 5%)
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