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| Product NDC Code | 83391-003 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Auvon pain relief roll-on |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SOLUTION | ||||||||
| RxCUI drug identifier | 283438 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | SHENZHEN YUWEN E-COMMERCE CO., LTD. | ||||||||
| 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 i ngredient s Menthol 4%
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 Rub a thin film over the affected area not more than 3 to 4 times daily Wash hands after use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, IsopropyI Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Aminomethyl Propanol, 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.Use Temporary relief from minor aches and pains of sore muscles and joints
Purpose
Information about the drug product’s indications for use.Purpose s Topical Analgestic
Spl product data elements
Usually a list of ingredients in a drug product.AUVON Pain Relief Roll-on menthol GLYCERIN WATER ALOE VERA LEAF ARCTIUM LAPPA WHOLE ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CAMPHOR (NATURAL) CARBOMER 940 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE MELISSA OFFICINALIS LEAF POLY(METHYL METHACRYLATE; 450000 MW) AMINOMETHYLPROPANOL .ALPHA.-TOCOPHEROL ACETATE 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.image description
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.MENTHOL AUVON Pain Relief Roll-on 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 are under 12 years of age, please consult a doctor If you are allergic to the listed ingredients If the package arrives damaged or opened. If you are pregnent or breast feeding At the same time as other topical analgesics On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin
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 and pets. If ingested, get medical help right away.
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.Discontinue use and consult a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering
Storage and handling
Information about safe storage and handling of the drug product.Storage Store it in a dry place at room temperature between 20-25 C (68-77F) and away from direct sunlight.
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 Please read all directions and warnings as follows and use only as directed. For external use only Do not use If you are under 12 years of age, please consult a doctor If you are allergic to the listed ingredients If the package arrives damaged or opened. If you are pregnent or breast feeding At the same time as other topical analgesics On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin Discontinue use and consult a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering Keep out of reach of children and pets. If ingested, get medical help 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