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Product NDC Code | 58559-002 | ||||||||||||
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Drug Name | Relief pain relieving cream |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | CREAM | ||||||||||||
RxCUI drug identifier | 1442261 | ||||||||||||
Application Number | M017 | ||||||||||||
Labeler Name | Corganics, LP | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Menthol 3%
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 years old and older: apply a small amount to affected area not more than 3 to 4 times daily. Gently massage until absorbed. Children under 2 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Eucalyptus Globulus Leaf Oil, Glycerine, L-Arginine Monohydrochloride, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Methylsulfonylmethane, Phenoxyethanol, Potassium Hydroxide, Tocopheryl Acetate
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.USAGE For the 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 Counterirritant
Spl product data elements
Usually a list of ingredients in a drug product.Relief Pain Relieving Cream MENTHOL MENTHOL MENTHOL ALOE BENZYL ALCOHOL CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE CARBOMER COPOLYMER TYPE A POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL CETYL ALCOHOL ORANGE OIL PALMAROSA OIL WATER EUCALYPTUS OIL GLYCERIN ARGININE LAVENDER OIL HYDROGENATED SOYBEAN LECITHIN DIMETHYL SULFONE PEPPERMINT OIL PHENOXYETHANOL POTASSIUM HYDROXIDE .ALPHA.-TOCOPHEROL ACETATE
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.CONTAINER 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 OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
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 the eyes. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again after a few days, discontinue use of this product and consult a physician. Do Not Use on wounds or damaged skin when bandaged tightly or with a heating pad with other topical products
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