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| Product NDC Code | 84269-3500 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocaine hydrochloride |
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| Type | Generic | ||||
| 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 | LIQUID | ||||
| RxCUI drug identifier | 1010769 | ||||
| Application Number | M017 | ||||
| Labeler Name | Wildman Business Group | ||||
| 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 ingredients 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 for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily for children under 2 years of age consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, germaben II, propylene glycol, purified water Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com PAIN RELIEF – Burn Spray Safetec of America Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ----------
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 Temporary pain relief for minor burns
Purpose
Information about the drug product’s indications for use.Purpose Topical pain relief
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Hydrochloride Lidocaine Hydrochloride ALOE VERA LEAF PROPYLENE GLYCOL DIAZOLIDINYL UREA WATER 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 – 2 oz. bottle Provision First Aid Burn Spray For Temporary Pain Relief of Minor Burns 2fl. oz. (59.1ml) Reorder no. 3500 Principal Display Panel Burn Spray
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.Drug Facts
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 or blistered areas near eyes, if this happens rinse thoroughly with water Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns
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 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 persists for more than 7 days or clears up and returns
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 or blistered areas near eyes, if this happens rinse thoroughly with water Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns Keep out of reach of children. If swallowed get medical help or contact 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