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| Product NDC Code | 0280-0049 | ||||
|---|---|---|---|---|---|
| Drug Name | Alevex |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M017 | ||||
| Labeler Name | Bayer HealthCare 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 (To Deliver) Camphor 5.5% Menthol 16%
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 12 years of age and older Shake well before use Apply to affected area not more than 3 to 4 times daily Do not apply to face Use in a well-ventilated area and avoid inhalation Wash hands with soap and water after use if product comes in contact with hands Children under 12 years of age Ask a doctor
| Adults and children 12 years of age and older |
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| Children under 12 years of age |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients boswellia carterii oil, clove oil, dimethylaminoethyl methacrylate copolymer, dimethyl isosorbide, eucalyptus oil, fragrance, isobutane, isopentane, isopulegol, linseed oil, menthoxypropanediol, pepermint oil, propane, propanediol, rosemary oil, SD alcohol 40-B (13% v/v), thymus mastichina flower oil, tocopherol, vanillyl butyl ether, vinyl caprolactam, vinylpyrrolidone
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.For the temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains sprains bruises Provides penetrating pain relief
Purpose
Information about the drug product’s indications for use.Purpose Pain Relieving Spray
Spl product data elements
Usually a list of ingredients in a drug product.AleveX camphor and menthol CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ISOBUTANE PEPPERMINT OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) ALCOHOL PROPANEDIOL ROSEMARY OIL PROPANE MENTHOL MENTHOL FRANKINCENSE OIL DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER LINSEED OIL TOCOPHEROL 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL ISOPENTANE VANILLYL BUTYL ETHER N-VINYLCAPROLACTAM THYMUS MASTICHINA FLOWERING TOP OIL ISOPULEGOL N-VINYLPYRROLIDINONE CLOVE OIL DIMETHYL ISOSORBIDE EUCALYPTUS OIL
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 label display ALEVEX™ PAIN RELIEVING SPRAY MAX STRENGTH MENTHOL COOLS IN SECONDS FOR EXTERNAL USE ONLY NET WT 3.2 OZ (91 g) AleveX Dry Spray 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 use if you have ever had an allergic reaction to this product or any of its ingredients
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.If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 20º-25ºC (68º-77ºF)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-800-395-0689
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days
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.When using this product avoid contact with the eyes and mucous membranes use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF do not bandage tightly do not use with a heating pad, medicated patch or other types of local heat do not apply to wounds or damaged, broken or irritated skin
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before 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 Flammable : do not use near heat, flame, or while smoking. Do not use if you have ever had an allergic reaction to this product or any of its ingredients When using this product avoid contact with the eyes and mucous membranes use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF do not bandage tightly do not use with a heating pad, medicated patch or other types of local heat do not apply to wounds or damaged, broken or irritated skin Stop use and ask a doctor if condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. 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