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| Product NDC Code | 65121-113 | ||||
|---|---|---|---|---|---|
| Drug Name | Oxyrub pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 416982, 1421663 |
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| Application Number | M017 | ||||
| Labeler Name | Pure Source, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient 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 . Apply to affected area no more than 3-4 times daily. consult a doctor. Adults and children 12 years of age and older Children under 12 years of age,
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Bitter Orange Oil, C13-14 Isoparaffin, Caprylhydroxomic Acid, Caprylyl Glycol, Eucalyptus Oil, Glycerin, Laureth-7, Oxidized Corn Oil, Polyacrylamide (1000 MW), Polysorbate 20, 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 temporarily relieves minor aches and pains of muscles and joints associated simple backaches arthritis strains sprains bruises
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.OxyRub Pain Relief MENTHOL BITTER ORANGE OIL C13-14 ISOPARAFFIN CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL EUCALYPTUS OIL GLYCERIN LAURETH-7 CORN OIL POLYSORBATE 20 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.OxyRub Pain Relief Cream 4oz/114g (65121-113-04) OxyRub
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.OxyRub Pain Relief Cream
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature. For Lot Number and Expiration Date, see crimp at end of tube.
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. Do not use redness over the affected area t Ask a doctor before use if you have When using this produc Stop use and consult a doctor if Use only as directed. with a heating pad, may blister skin on open wounds or damaged skin Avoid contact with eyes Do not bandage tightly skin redness or excessive skin irritation develops condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again in a few days
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