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| Product NDC Code | 73168-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Uriflex fast acting analgesic pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2171392 | ||||
| Application Number | M017 | ||||
| Labeler Name | Rejuvica 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 Ingredients Menthol 4.50% Purposes External Analgesic
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 directly to affected area. Do not use more than four times per day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, Methyl Salicylate, PEG-8, Propyl Paraber, Propylene Glycol, Sodium Laruyl Sulfate, Triethanolamine.
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 associated with simple backache, arthritis, bruises, sprains, and strains.
Purpose
Information about the drug product’s indications for use.Purposes External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.URIFLEX Fast Acting Analgesic Pain Relief MENTHOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALOE VERA LEAF WATER CETYL ALCOHOL DIAZOLIDINYL UREA ISOPROPYL MYRISTATE METHYLPARABEN METHYL SALICYLATE POLYETHYLENE GLYCOL 400 PROPYLPARABEN PROPYLENE GLYCOL SODIUM LAURYL SULFATE TROLAMINE 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.Package Labeling: 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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT Apply to Open Wounds or Damaged Skin. If symptoms persist for more than seven days, discontinue use and consult physician.
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, consult physician. Do not bandage tightly.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, contact physician prior to use.
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. DO NOT Apply to Open Wounds or Damaged Skin. If symptoms persist for more than seven days, discontinue use and consult physician. KEEP OUT OF REACH OF CHILDREN. If swallowed, consult physician. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to use.
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