New Terocin
FDA Label NDC 68258-3981

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product New Terocin (NDC 68258-3981). 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, uses, warnings, keep out of reach of children., directions, inactive ingredients, package/label principal display panelndc 68258-3981-04, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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.

Package/Label Principal Display Panelndc 68258-3981-04

NDC 50488-1129-1

New Terocin

Topical Pain

Relief Lotion

Long Lasting

Soothing Effect

120 ml (4 fl oz.)

Manufactured for: Alexso Inc.

Thousand Oaks, CA 91360

Made in U.S.A.

Patent Pending

Store in a dry, cool place

For Comments or Questions,

call 888-495-6075

Bottle Label

Bottle Label

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