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Product NDC Code | 35356-963 | ||||||
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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 | M017 | ||||||
Labeler Name | Quality Care Products, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 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.
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 MENTHOL WATER PROPYLENE GLYCOL CETYL ALCOHOL STEARIC ACID GLYCERYL MONOSTEARATE PEG-100 STEARATE DIMETHYL SULFONE LIDOCAINE LAVENDER OIL ALOE VERA LEAF BORAGE 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.image description
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. Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.
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