Active Ingredient
Lidocaine HCl 4%
Blue-emu Lidocaine Pain Relief Cream
FDA Label NDC 69993-350
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kingsway Pharmaceuticals Dba Nfi, Llc for the product Blue-emu Lidocaine Pain Relief Cream (NDC 69993-350). 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, stop use and ask doctor if, keep out of reach of children and pets, purpose, warnings, do not use, when usig this product, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Stop Use And Ask Doctor If
- Condition worsens
- symptoms persist for more than 7 days or clear up and occur again in a few days
Keep Out Of Reach Of Children And Pets
If swallowed, get medical help or contact Poison Control Center right away.
Purpose
Topical analgesic
Warnings
For external use only
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 a doctor
When Usig This Product
Use only as directed. Read and follow all directions and warnings on the carton.
- do not allow contact with the eyes
- do not bandage or or apply local heat (such as heating pads) to the area of use.
If Pregnant Or Breast Feeding
ask a health professional before use.
Directions
Adults and Children over 12 years:
apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.
Children 12 years or younger: ask a doctor
Inactive Ingredients
acrylates/acrylamide copolymer, allantoin, aloe barbadensis (Aloe Vera) leaf juice, allantoin, caprylic/capric triglyceride, cetyl alcohol, dimethicone, d-panthenol, emu oil, ethylhexylglycerin, glycerin, glyceryl stearate and PEG 100, mineral oil, phenoxyethanol, polysorbate 80, polysorbate 85, sodium polyacrylate, stearic acid, triethanolamine, tocopherol acetate (Vitamin E), water
Uses
For the temporary relief of pain
* Please review the disclaimer below.
