FDA Label for Topicaine
View Indications, Usage & Precautions
Topicaine 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 4% w/w
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:
Label affixed to Topicaine 4% 30 gram tubes:
Outer box of Topicaine 4% 30 grams:
Label affixed to tubes of Topicaine 4% 113 grams:
* Please review the disclaimer below.
