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Product NDC Code | 80425-0256 | ||||||
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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 | Advanced Rx Pharmacy of Tennessee, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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.As directed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.Consult your physician
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.New Terocin Methyl Salicylate, Capsaicin, and Menthol POLYSORBATE 20 POLYSORBATE 60 INDIAN FRANKINCENSE STEARYL ALCOHOL ALKYL (C12-15) BENZOATE MENTHOL MENTHOL CETOSTEARYL ALCOHOL DIAZOLIDINYL UREA WATER PROPYLENE GLYCOL GLYCERYL MONOSTEARATE PEG-100 STEARATE LAVENDER OIL BORAGE SEED OIL PROPYLPARABEN METHYL SALICYLATE SALICYLIC ACID CAPSAICIN CAPSAICIN ALOE VERA LEAF CETYL ALCOHOL STEARIC ACID DIMETHYL SULFONE XANTHAN GUM TROLAMINE METHYLPARABEN DMDM HYDANTOIN
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.label 1
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Uses Temporarily relieves mild aches and pains of muscles or joints.
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.
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.Consult physician for children under 12.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Bottle of: 120ml NDC: 80425-0256-01
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.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