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Burn relief - Medication Information

Product NDC Code 69842-236
Drug Name

Burn relief

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine .64 g/127g
Route TOPICAL
Dosage Form AEROSOL, SPRAY
RxCUI drug identifier 1442274
Application Number M017
Labeler Name CVS Pharmacy
Packages
Package NDC Code Description
69842-236-45 127 g in 1 canister (69842-236-45)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients 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 for adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily for children under 2 years of age, ask a doctor to apply to face spray in palm of hand and gently apply

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients aloe barbadensis leaf juice, 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 relief of pain and itching associated with: 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.
Burn Relief Lidocaine CARBOMER HOMOPOLYMER TYPE C DISODIUM COCOAMPHODIPROPIONATE EDETATE DISODIUM EDETIC ACID METHYLPARABEN PROPANE TROLAMINE WATER PROPYLPARABEN DIAZOLIDINYL UREA ALOE VERA LEAF GLYCERIN .ALPHA.-TOCOPHEROL ACETATE LIDOCAINE LIDOCAINE BUTANE PROPYLENE GLYCOL

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 CVS Health Fast Acting Burn Relief Spray Lidocaine 0.5% EXTERNAL ANALGESIC Relieves pain and itching from sunburn, minor burns and insect bites Cools, moisturizes and soothes sunburned skin NET WT 4.5 OZ (127 g) burn relief spray

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.

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 (68º and 77ºF)

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 condition gets worse symptoms last more than 7 days or clears up and occurs again in 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 ask a doctor before using on children under 2 years of age

Safe handling warning

Safe Handling Warning
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. Intentional misuse by delibrately concentrating and inhaling the contents can be harmful or fatal.

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. Intentional misuse by delibrately concentrating and inhaling the contents can be harmful or fatal. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product do not get into eyes ask a doctor before using on children under 2 years of age Stop use and ask a doctor if condition gets worse symptoms last more than 7 days or clears up and occurs again in 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