Blue-emu Thrive Pain Relief Cream
FDA Label NDC 69993-600

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 Pain Relief Cream (NDC 69993-600). 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, 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

Active Ingredient

Tripelennamine HCL 0.5% w/w

Purpose

Topical Analgesic

Use:

Temporarily relieves pain associated with:

  • insect bites
  • minor burns
  • minor cuts
  • minor skin irritations
  • scrapes
  • sunburn
  • rashes due to: poison ivy, poison oak, or poison sumac

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 (Horse Chestnut) Extract, Allantoin, Aloe Barbadensis Leaf Juice (Aloe Vera), Calendula Officinalis (Calendula) Extract, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Flower Extract, Cholecalciferol, Dimethicone, Dimethyl Sulfone (MSM), Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine HCL, Glycerin, Mineral Oil, Oleyl Alcohol, Panthenol, Phenoxyethanol, Polysorbate 85, Retinyl Palmitate, Stearic Acid, Symphytum Officinale (Comfrey Root) Extract, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water (Aqua), Zanthoxylum Alatum Fruit Extract

Principal Display Panel – Jar Label

BLUE-EMU®
THRIVE
PAIN RELIEF CREAM
 
Topical Cream     NET WT 3 OZ/85g

Image-01 (Lidocaine 01)

Image-01 (Lidocaine 01)

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