Active Ingredients
Tripelennamine HCL 0.5% w/w
Blue-emu Thrive Cooling Cream
FDA Label NDC 69993-650
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 Thrive Cooling (NDC 69993-650). 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 ingredients, purpose, use, warnings:, do not use, if pregnant or breast-feeding,, keep out of reach of children and pets., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
Temporarily relieves minor pain
Warnings:
For external use only.
Avoid contact with the eyes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Do Not Use
if packaging is damaged or opened.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
Adults and children 2 years of age and older:
Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult a physician.
Storage Information:
Protect from freezing and excessive heat, store at 68°-77°F (20°-25°C).
Inactive Ingredients
Acrylates/ Acrylamide Copolymer, Aesculus Hippocastanum Extract, Allantoin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Cetyl Alcohol, Chamomilla Recutita Flower Extract, Cholecalciferol, Dimethicone, Dimethyl Sulfone (MSM), Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine HCL, Glycerin, Menthyl Lactate, Mineral Oil, dL-Panthenol, Phenoxyethanol, Polysorbate 85, Retinyl Palmitate, Stearic Acid, Symphytum Officinale Extract, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water (Aqua)
KINGSWAY™
PHARMACEUTICALS
MANUFACTURED IN THE USA
Distributed By:
Kingsway Pharmaceuticals dba NFI Consumer Products
636 Shelby Street, Suite 300, Bristol, TN 37620
800-432-9334 • www.blue-emu.com
CONTAINS EMU OIL
LIVE LIFE
ON YOUR TERMS
WWW.BLUE-EMU.COM
Principal Display Panel – Tube Label
LIVE LIFE
ON YOUR TERMS
COOLING SENSATION
BLUE-EMU®
THRIVE
DEEP
PENETRATING
POWERFUL
PAIN RELIEF
CREAM
The only topical pain
cream with the power of
TRIPELENNAMINE HCL
and COOLING in one.
TOPICAL CREAM NET WT 3OZ/85G
Image-01 (Lidocaine 01)
* Please review the disclaimer below.
