Active Ingredient
Lidocaine 4% w/w
Topicaine Gel
FDA Label NDC 63135-312
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 Topicaine (NDC 63135-312). 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, stop use and ask a doctor if:, keep out of the reach of children, directions, inactive ingredients, 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.
Warnings
For external use only
Flammable
Keep away from sparks, heat and fire. Cap tube tightly when not in use.
Stop Use And Ask A Doctor If:
- allergic reaction occurs
- condition worsens or does not improve within 7 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.
Directions
Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40B, Simmondsia Chinensis (Jojoba) Seed Oil, Water
Questions
Call toll-free in USA & Canada 800-677-9299 or visit www.topicaine.com
Labelling On Tubes And Outer Cartons
Labelling printed on tube of Topicaine 4% 10 gram tube:
Outer carton of Topicaine 4% 10 grams:
Box Of Topicaine 4% 10 Grams (Box For Topicaine 4 10 G Tubes Cder 1 15 2019)
Label affixed to Topicaine 4% 30 gram tubes:
Outer box of Topicaine 4% 30 grams:
Label affixed to tubes of Topicaine 4% 113 grams:
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