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Product NDC Code | 68788-7821 | ||||||
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Drug Name | New terocin |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LOTION | ||||||
RxCUI drug identifier | 1372464 | ||||||
Application Number | part348 | ||||||
Labeler Name | Preferred Pharmaceuticals Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients: Methyl Salicylate 25% Capsaicin 0.025% Menthol 10%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: Temporarily relieves mild aches and pains of muscles or joints.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.New Terocin Methyl Salicylate, Capsaicin, and Menthol METHYL SALICYLATE SALICYLIC ACID CAPSAICIN CAPSAICIN MENTHOL, UNSPECIFIED FORM MENTHOL WATER PROPYLENE GLYCOL CETYL ALCOHOL STEARIC ACID GLYCERYL MONOSTEARATE PEG-100 STEARATE DIMETHYL SULFONE LIDOCAINE LAVENDER OIL ALOE VERA LEAF BORAGE SEED OIL INDIAN FRANKINCENSE XANTHAN GUM TROLAMINE METHYLPARABEN PROPYLPARABEN DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel NDC 68788-7821-1 New Terocin Topical Pain Relief Lotion Long Lasting Soothing Effect 120 ml (4 fl oz.) Manufactured for: Alexso Inc. Los Angeles, CA 90064 Store in a dry, cool place Made in U.S.A. Patent Pending For Comments or Questions, call 888-495-6075 Relabeled By: Preferred Pharmaceuticals Inc. Label Terocin Topical Pain Releif Lotion
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Consult your physician: if pain is persistent or worsens or if using any other topical pain products.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do Not Use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. Consult physician for children under 12.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API