Active Ingredient
Lidocaine 4% w/w
Lubricaine Gel
FDA Label NDC 63135-727
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 (NDC 63135-727). 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, uses, warnings, 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
Topical Anesthetic
Uses
For the temporary relief of pain and itching
Warnings
For external use only.
When Using This Product
- do not use in or near the eye
- do not use in large quantities, particularly over raw surfaces or blistered areas
- do not exceed recommended dosage unless directed by a doctor
Stop Use And Ask A Doctor If
- allergic reaction occurs
- condition worsens or does not improve within seven days
- symptoms clear up and return within a few days
- you notice any unusual effects
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
Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to affected area no more than 3 to 4 times a day
Other Information
- Store at room temperature 20-25 oC (68-77 oF)
- Tamper evident: do not use if foil under cap is damaged or mising.
- Child-Resistant Cap: push down and turn to open
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Citric Acid, Dehydroacetic Acid, Dipotassium Glycyrrhizinate, Lactic Acid, Natural Flavors, Potassium Sorbate, Purified Water, Stevia Rebaudiana Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Xanthan Gum.
Questions
Call toll-free in USA & Canada 800-677-9299 9 am to 5 pm Eastern Time M-F or visit www.esbalabs.com
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