Active Ingredient
Lidocaine 5% w/w
Topicaine 5 Gel
FDA Label NDC 63135-581
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 5 (NDC 63135-581). 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, 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 and itching due to anorectal disorders.
Warnings
For external use only
Flammable Keep away from sparks, heat and fire. Cap tube tightly when not in use.
When Using This Product
- avoid contact with eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
- do not put in rectum
- do not exceed recommended dosage unless directed by a doctor
Stop Use And Ask A Doctor If:
- allergic reaction occurs
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- symptoms clear up and return within a few days
- redness, irritation, swelling, pain or other symptoms begin or increase.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Bisabolol, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40, Shea Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Water.
Directions
- When practical, clean area with mild soap and warm water and rinse thoroughly
- Gently dry by patting or blotting with toilet tissue or soft cloth before applying
- Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
- Children under 12 years of age: consult a doctor.
Label On Tube And Outer Carton
Labeling printed on tube of Topicaine 5% 10 g
Printed Tube Of Topicaine 5% 10 Grams (Top5 010 Label Printed On Tubes Label Revision Cder 2019)
Outer carton of Topicaine 5% 10 g tube
Label affixed to tube of Topicaine 5 % 30 g tube
Top5-030 Label (Top 5 30 G Tubes Label Labeling Update 1 15 2019 Cder Rev1)
Outer carton of Topicaine 5 % 30 g tube:
Topicaine 5 30 G Outer Carton Update (Top 5 30 G Outer Carton Labeling Update 1 15 2019 Cder)
Label affixed to tube to Topicaine 5% 113 g
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