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Burn jel - Medication Information

Product NDC Code 59898-200
Drug Name

Burn jel

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride 2 g/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1011852
Application Number part348
Labeler Name Water-Jel Technologies
Packages
Package NDC Code Description
59898-200-11 24 bottle, plastic in 1 carton (59898-200-11) / 59 ml in 1 bottle, plastic (59898-200-10)
59898-200-13 24 bottle, plastic in 1 carton (59898-200-13) / 118 ml in 1 bottle, plastic (59898-200-12)
59898-200-15 25 packet in 1 box (59898-200-15) / 3.5 ml in 1 packet
59898-200-16 6 packet in 1 box (59898-200-16) / 3.5 ml in 1 packet
59898-200-17 1728 packet in 1 carton (59898-200-17) / 3.5 ml in 1 packet
59898-200-35 3.5 ml in 1 packet (59898-200-35)
59898-200-49 10 packet in 1 kit (59898-200-49) / 3.5 ml in 1 packet
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Lidocaine HCl 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 and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily spread a thick even layer over affected skin children under 2 years of age: consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acrylates/C10-30 alkyl acrylate, carbomer, diazolidinyl urea, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, triethanolamine, 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 associated with minor burns

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 Jel Lidocaine Hydrochloride CARBOMER HOMOPOLYMER TYPE C GLYCERIN PROPYLENE GLYCOL METHYLPARABEN TEA TREE OIL DIAZOLIDINYL UREA TROLAMINE OCTOXYNOL-9 CARBOMER HOMOPOLYMER TYPE B PROPYLPARABEN EDETATE DISODIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS

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 Principal Display Label BJ2RD BJ4RD

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.
Other information store at room temperature you may report a serious adverse reaction to this product to 800-275-3433

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 on large areas of the body on broken, blistered or oozing skin

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 or comments? 1-800-275-3433 [email protected] www.waterjel.com Manufactered by Water-Jel Technologies, Inc., 50 Broad Street, Carlstadt, NJ 07072, USA

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 worsens symptoms persist for more than 7 days condition 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 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 on large areas of the body on broken, blistered or oozing skin When using this product avoid contact with eyes Stop use and ask a doctor if conditions worsens symptoms persist for more than 7 days condition 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

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