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| Product NDC Code | 71101-050 | ||||
|---|---|---|---|---|---|
| Drug Name | Healthwise soothing cold therapy gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | Veridian Healthcare | ||||
| 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% Purpose Topical 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 Directions Adults and children 2 years of age and older: ■rub a thin film over affected area not more than 4 times daily, massage not necessary Children under 2 years of age: consult physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Inactive ingredients aloe barbadensis leaf juice, aminomethyl propanol,arctium lappa extract, arnica montana flower extract, Boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&Cyellow no.5, FD&C blue no.1, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol,isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, 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.Uses Uses Temporary relief from minor aches and pains of sore muscles and joints associated with: ■arthritis ■backache ■strains■sprains
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.HealthWise Soothing Cold Therapy Gel Menthol 4% PARAFFIN CEDAR LEAF OIL NUTMEG OIL THYMOL TURPENTINE OIL PETROLATUM 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.HealthWise Soothing Cold Therapy Gel 4% Menthol 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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have sensitive 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. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) 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 in a cool dry place do not use if tube seal under cap is broken
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 Stop use and ask a doctor if: the condition worsens, if the symptoms last more than 7 days or clear up and reoccur
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, do not When using this product: ■ avoid contact with eyes or mucous membranes ■ do not apply to wounds or damaged skin ■ do not use with other ointments, creams, sprays or liniments ■do not apply to irritated skin or if excessive irritation develops ■do not bandage ■ wash hands after use with cool water ■do not use with a heating pad or device
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: keep away from excessive heat or open flame Ask a doctor before use if you have sensitive skin When using this product, do not When using this product: ■ avoid contact with eyes or mucous membranes ■ do not apply to wounds or damaged skin ■ do not use with other ointments, creams, sprays or liniments ■do not apply to irritated skin or if excessive irritation develops ■do not bandage ■ wash hands after use with cool water ■do not use with a heating pad or device Stop use and ask a doctor if Stop use and ask a doctor if: the condition worsens, if the symptoms last more than 7 days or clear up and reoccur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) 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