Otc - Active Ingredient
Trolamine Salicylate 10%
Maximum Strength Blue Emu Pain Relief Spray
FDA Label NDC 69993-100
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 Maximum Strength Blue Emu Pain Relief (NDC 69993-100). 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 otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, otc - purpose, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses
Temporarily relieves pain associated with: arthritis, simple backache, muscle strains, sprains, bruises, and cramps.
Warnings
Warnings
For external use only. Allergy Alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product: use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucuous membranes, and do not apply to wounds or damaged skin. Stop use and ask doctor if: condition gets worse, symptoms persist for more than 7 days, or symptoms clear up and occur again in a few days, redness is present, or irritation develops.
Dosage & Administration
Directions
Shake well. 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: ask a doctor. To apply to face, spray into palm of hand and gently apply.
Inactive Ingredient
Inactive ingredients
Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Diazolidinyl Urea, Dimethyl Sulfone, Disodium EDTA, DMDM Hydantoin, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Lecithin, Oleic Acid, Panthenol, Phenoxyethanol, Polysorbate 20, Sorbitol, Water, and Xanthan Gum.
Otc - Purpose
Purpose
Topical analgesic.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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