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Product NDC Code | 54230-356 | ||||
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Drug Name | Celadrin joint and muscle pain relieving |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 416982, 1046429 |
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Application Number | M017 | ||||
Labeler Name | Factors Group of Nutritional Products | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol (1.25%)
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 2 yrs. of age and older: Apply to affected area not more than 3 to 4 times per day. Children under 2 yrs. of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Benzyl Alcohol, Butylparaben, Carbomer, Celadrin ® (a proprietary blend of esterified fatty acid carbons), Ethylparaben, Glycerin, Glyceryl Stearate, Isobutylparaben, Lecithin, Methylparaben, Olea europaea (Olive) Fruit oil, PEG-100 Stearate, Peppermint Oil, Phenoxyethanol, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Water.
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 For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
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.Celadrin Joint and Muscle Pain Relieving Menthol BENZYL ALCOHOL BUTYLPARABEN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE ISOBUTYLPARABEN LECITHIN, SOYBEAN METHYLPARABEN OLIVE OIL PEG-100 STEARATE PEPPERMINT OIL PHENOXYETHANOL SODIUM HYDROXIDE PROPYLPARABEN .ALPHA.-TOCOPHEROL ACETATE WATER 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.PRINCIPAL DISPLAY PANEL - 170 g Jar Label DEEP PENETRATING InflameAway ® Celadrin ® JOINT & MUSCLE PAIN RELIEVING CREAM FIMS GREASELESS FORMULA FAST ACTING RELIEF NET WT. 6 OZ. (170 G) Principal Display Panel - 170 g Jar Label
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.Drug Facts
Distributed by WN Pharmaceuticals ® Inc., Everett WA, USA 98203
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. If swallowed, get medical help or contact a poison control center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-430-7898
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician. Do not apply to wounds or damaged skin. Do not bandage tightly.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store in a cool, dry place.
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. Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician. Do not apply to wounds or damaged skin. Do not bandage tightly. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
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