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| Product NDC Code | 68016-614 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocaine |
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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 | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 1442274 | ||||
| Application Number | M017 | ||||
| Labeler Name | Chain Drug Consortium, LLC | ||||
| 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 0.5%
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 shake can well adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily to apply to face spray in palm of hand and gently apply for children under 2 years of age, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis gel, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, tocopheryl acetate (vitamin E acetate), triethanolamine, simethicone, 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 for the temporary relieves pain and itching due to: sunburn minor burns 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.Lidocaine Burn Relief ALOE VERA LEAF BUTANE CARBOMER 940 DIAZOLIDINYL UREA DISODIUM COCOAMPHODIPROPIONATE EDETATE DISODIUM GLYCERIN METHYLPARABEN PROPANE PROPYLENE GLYCOL PROPYLPARABEN .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER LIDOCAINE LIDOCAINE
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 Premier Value Aloe Burn Relief Spray Relieves Pain with Lidocaine HCl Cools Moisturizes Relieves itching Net WT 4.5 (127g) PV Burn Relief Spray.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. Do not use on children under 2 years of age unless directed by a doctor.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 20º and 25ºC (68ºF and 77º)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted. Questions? call 1-866-964-0939
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 conditions gets worse symptoms last more than 7 days symptoms clear up and occurs again in 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 keep out eyes only as directed do not puncture or incinerate Contents under pressure. Do not store at temperature above 120 o F
Safe handling warning
Safe Handling WarningFlammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF
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: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product keep out eyes only as directed do not puncture or incinerate Contents under pressure. Do not store at temperature above 120 o F Stop use and ask a doctor if conditions gets worse symptoms last more than 7 days symptoms clear up and occurs again in few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.
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