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Product NDC Code | 62212-505 | ||||
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Drug Name | Menthol |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 727161 | ||||
Application Number | part348 | ||||
Labeler Name | Amish Origins LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 8%
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 Adults and children over 12 years: Apply freely to affected areas. Rub well Colds: Apply on chest, back and neck. Head Colds : Apply around nostrils, on forehead and behind ears. Place small amount in vaporizer for aid. Sore Throat: Apply liberally on throat and neck for sore throats Children 12 years or younger. Consult your physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis (Aleo Vera) Leaf Juice, Beeswax, Hydrogenated Castor oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Chlorphenesin, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride
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: Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome
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.Menthol Owell Naturals Pain Relief Cream WATER SAFFLOWER OIL SUNFLOWER SEED OIL GLYCERETH-8 ESTERS CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) SODIUM CHLORIDE ALOE VERA LEAF HYDROGENATED CASTOR OIL PHENOXYETHANOL CAPRYLYL GLYCOL CHLORPHENESIN EUCALYPTUS GLOBULUS LEAF CINNAMOMUM CAMPHORA WHOLE ABIES SIBIRICA LEAF OIL METHYL SALICYLATE MENTHOL MENTHOL
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.7FL OZ Pain Relief Cream label
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 ointment out of reach of children
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 For External Use Only, As Directed! Avoid contact with eyes or other sensitive areas. If prone to allergic reaction from asprin or salicylate, consult your doctor before using. If conditions persist pore than seven days, consult your doctor If pregnant or breast-feeding, ask a health professional before use. Do not bandange tightly or use a heating pad May irritate sensitive skin Keep ointment out of reach of children
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