New Terocin Lotion
FDA Label NDC 50090-1353

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product New Terocin (NDC 50090-1353). 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:, keep out of reach of children., directions:, inactive ingredients:, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

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.
  • Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.

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:

Water (Aqua), Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Dimethyl Sulfone, Lavandula Angustifolia (Lavendar) Oil, Lidocaine, Aloe Barbadensis Leaf Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Xanthan Gum, Triethanolamine, Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

How Supplied

Product: 50090-1353

NDC: 50090-1353-0 120 mL in a BOTTLE

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