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| Product NDC Code | 56062-942 | ||||
|---|---|---|---|---|---|
| Drug Name | Burnrelief |
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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 | ||||
| Application Number | part348 | ||||
| Labeler Name | Publix | ||||
| 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 Lidocaine HCl
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 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.inactive ingredients water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, diazolidinyl urea, menthol, disodium EDTA, blue 1, yellow 5
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 for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations
Purpose
Information about the drug product’s indications for use.purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.burnrelief Lidocaine HCl LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WATER PROPYLENE GLYCOL GLYCERIN ALOE VERA LEAF TROLAMINE ISOPROPYL ALCOHOL POLYSORBATE 80 CARBOXYPOLYMETHYLENE DIAZOLIDINYL UREA MENTHOL EDETATE DISODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5
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.principal display panel Publix burnrelief AFTER SUN ALOE PAIN RELIEVING GEL SUNBURN RELIEF WITH LIDOCAINE HCl NET WT 8 OZ (226 g) 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.DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811 publix.com PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK
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, get medical help or contact a Poison Control Center 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.Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clean up and occur again within a few days
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
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