Active Ingredient
Lidocaine 4%
Lidocaine Pain Relief Spray
FDA Label NDC 69396-178
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Lidocaine Pain Relief (NDC 69396-178). 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, warnings, uses, when using this product, ask doctor before use, do not use, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Warnings
For External Use Only
Extemely Flammable
- do not use near heat or flame or while smoking
- avoid long term storage above 104°F (40°C)
- do not puncture or incinerate. Contents under pressure
- do not store at temerature above 120°F (49°C).
Uses
Temporarily relieves minor pain
When Using This Product
- Use only as directed. Read and follow all directions and warnings on this label.
- do not allow contact with the eyes and mucous membranes
- avoid spraying on face
- avoid inhalation of spray
- do not bandage or apply local heat such as heating pads or a medeicated patch to area of use
- do not sue at thesame timea s other topical analgesics.
Ask Doctor Before Use
Ask doctor before use if you have
- Deep or puncture wounds
- Animal Bites
- Serious burns
Do Not Use
Do not use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting doctor
Stop Use And Ask A Doctor
- If condition worsens
- redness is present
- irritation develops
- sysmptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Pregnant Or Breast Feeding
ask a health professional before use.
Directions
Adults and children over 12 years
- Spray affected area every 6 to 8 hours, not to exceed 3 applications i n a 24 hour period.
- Product will dry quickly on its own and does not need to be rubbed in
Children 12 years or younger: ask a doctor
Other Information
- Store at controlled room temperature 68°-77°F (20°-25°C)
Inactive Ingredients
Caprylic Capric triglyceride, propylene glycol, SD alcohol, Water
Questions Or Comments
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA, LLC.
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 6001
* This product is not manufactured or distributed by Chattem Inc. the distributor of Aspercreme®.
* Please review the disclaimer below.
