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Product NDC Code | 0363-0290 | ||||
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Drug Name | Walgreens burn relief |
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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 | 1291672 | ||||
Application Number | part348 | ||||
Labeler Name | Walgreens | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine HCl 4%......................................................................................................................... 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 adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe barbadensis (aloe vera) leaf juice, caprylyl glycol, chlorphensin, dimethyl isosorbide, hydroxyethyl cellulose, phenoxyethanol, propanediol, purified water, vitamin E
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 Temporarily relieves pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Burns Relief topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Walgreens Burn relief Lidocaine Hydrochloride HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) PHENOXYETHANOL CAPRYLYL GLYCOL ALOE VERA LEAF PROPANEDIOL DIMETHYL ISOSORBIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WATER CHLORPHENESIN .ALPHA.-TOCOPHEROL ACETATE
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.Prncipal Display Panel Walgreens Burn Gel LIDOCAINE HCl 4% Compare to Alocane® active ingredient†† TOPICAL ANALGESIC + Vitamin E Maximum Strength + Aloe • Fast pain & itch relief • Use on sunburns & minor burns Burn Gel .jpg
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 surfaces 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 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 doctor if condition gets worse symptoms last for more than 7 days symptoms 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 Do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store between 20 °C and 25 °C (68 °F and 77 °F)
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 surfaces or blistered areas When Using This Product Do not get into eyes Stop use and ask doctor if condition gets worse symptoms last for more than 7 days symptoms clear up and occur again within a few days Keep out of 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