Active Ingredients:
Methyl Salicylate 25%
Capsaicin 0.025%
Menthol 10%
New Terocin Lotion
FDA Label NDC 87063-194
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Asclemed Usa Inc. for the product New Terocin (NDC 87063-194). 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, uses:, warnings, do not use:, consult your physician:, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
Temporarily relieves mild aches and pains of muscles or joints.
Warnings
Only for external use.
Do Not Use:
on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
Consult Your Physician:
if pain is persistent or worsens or if using any other topical pain products.
Keep Out Of Reach Of Children.
Consult physician for children under 12.
Directions:
Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes.
Inactive Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Borago Officinalis (Borage) Seed Oil, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Diazolidinyl Urea, Dimethyl Sulfone (DMSO), DMDM Hydantoin, Glyceryl Stearate, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Polysorbate-60, Propyl Paraben, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum.
Other
Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
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