Drugplain

TOPICAINE 4 g/100g

LIDOCAINE 4% · GEL · ESBA LABORATORIES INC.

No Recall HistoryCurrently in Shortage
Plain English

Topicaine is a topical gel containing 4% lidocaine that you can apply directly to your skin to numb minor pain and itching. It's an over-the-counter local anesthetic available without a prescription.

Key Facts

Brand Name
TOPICAINE
Generic Name
LIDOCAINE 4%
NDC Code (Product)
63135-312
Manufacturer
ESBA LABORATORIES INC.
Strength
4 g/100g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Amide Local Anesthetic [EPC]; Antiarrhythmic [EPC]
Marketing Start
04/20/2003

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea33 reports
drug ineffective31 reports
pain25 reports
headache23 reports
dizziness18 reports
hypotension18 reports
off label use18 reports
vomiting18 reports
fatigue15 reports
anaesthetic complication12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of pain and itching due to anorectal disorders.

Dosage & Administration

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.

Warnings

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.

Frequently Asked Questions

What is TOPICAINE used for?

Topicaine is a topical gel containing 4% lidocaine that you can apply directly to your skin to numb minor pain and itching. It's an over-the-counter local anesthetic available without a prescription.

Is TOPICAINE a controlled substance?

TOPICAINE is not classified as a controlled substance by the DEA.

What is the generic name for TOPICAINE?

The generic name for TOPICAINE is LIDOCAINE 4%. There are 12 other brand versions of LIDOCAINE 4%.

What is the NDC code for TOPICAINE 4 g/100g?

The NDC (National Drug Code) for TOPICAINE 4 g/100g is 63135-312, listed by ESBA LABORATORIES INC..

Product NDC

63135-312

Package NDC

63135-312-04

Other Lidocaine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)