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Drug Facts
Distributed by:
Pacific Shore Holdings, Inc.
Chatsworth, CA 91311
Thermal-aid
FDA Label NDC 69314-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pacific Shore Holdings, Inc. for the product Thermal-aid (NDC 69314-201). 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 other, otc - purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purpose |
|---|---|
| Bryonia 6x HPUS 0.1% | Muscle aches and stiffness |
| Rhus Toxicodendron 6x HPUS 0.1% | Muscle pain and stiffness |
Uses
External analgesic for temporary relief of headache and migraine pain.
Warnings
For external use only. Avoid contact with eyes and open wounds.
Otc - Stop Use
Stop use and ask a doctor if condition persists for more than 7 days or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of ingestion, seek professional assistance or contact a poison control center.
Directions
Adults and children age 12 and older: Apply a small amount of cream to forehead and temples, and massage into skin. Use as needed and when headache pain flares up.
Other Information
Store at 68 to 77 degrees Fahrenheit.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Steric Acid, Polysorbate 60, Cocos Nucifera (Coconut) Oil, Cetyl Alcohol, Cetearyl Alcohol, Propylene Glycol, Mineral Oil, Myristyl Myristate, Glycine Soja (Soybean) Oil, Sodium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Menthol, Tocopheryl Acetate, Squalene, Soluble Collagen, Hydrolyzed Elastin, Allium Sativum (Garlic) Bulb Extract, Glycerin, Caprylhydroxamic Acid, Benzyl Alcohol.
Principal Display Panel - 57 G Tube Label
thermal-AID®
Headache Relief Cream
Fast, Safe, Powerful Relief You Can Count On
NET WT 2 OZ. (57g)
Principal Display Panel (57 g Tube Label)
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