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| Product NDC Code | 47682-477 | ||||
|---|---|---|---|---|---|
| Drug Name | Medi-first burn |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1011852 | ||||
| Application Number | M015 | ||||
| Labeler Name | Unifirst First Aid Corporation | ||||
| 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 (in each gram) Lidocaine HCI 2.0%
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 & children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate
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 the temporary relief of pain associated with minor burns.
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.Medi-First Burn Lidocaine Hydrochloride ALOE VERA LEAF DIAZOLIDINYL UREA PROPYLENE GLYCOL WATER MENTHOL TROLAMINE .ALPHA.-TOCOPHEROL ACETATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS PROPYLPARABEN METHYLPARABEN
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.Medi-First Burn Gel Label Medi-First ® Burn Gel Lidocaine HCl / Topical Analgesic Product # 47769 NET CONTENTS: 6 Units of 1/8 oz MF BurnGel
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 in large quantities, particularly over raw or blistered areas
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-634-7680 Mfg. for Medique Products, 17080 Alico Commerce Ct., Ste 1, Fort Myers, FL 33967
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 ask a doctor if condition worsens symptoms persist for more than 7 days or clears up and occurs 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
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 in large quantities, particularly over raw or blistered areas When using this product avoid contact with the eyes Stop use ask a doctor if condition worsens symptoms persist for more than 7 days or clears up and occurs again within a few days Keep out of the reach of children. 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