FDA Label for Lubricaine 5
View Indications, Usage & Precautions
Lubricaine 5 Product Label
The following document was submitted to the FDA by the labeler of this product Esba Laboratories 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%
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.
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