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| Product NDC Code | 61010-5000 | ||||||||||||||
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| 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 | GEL | ||||||||||||||
| RxCUI drug identifier | 1011852 | ||||||||||||||
| Application Number | M017 | ||||||||||||||
| Labeler Name | Safetec of America, Inc. | ||||||||||||||
| Packages |
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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 for adults and children 2 years and older: apply to affected area not more than 4 times daily children under 2: do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate
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 MENTHOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE 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 – 0.125 oz. packet NDC 61010-5000-0 Safetec Burn Gel For Temporary Pain Relief of Minor Burns 0.125 oz. (3.7 ml) Reorder no. 50000 Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com PRINCIPAL DISPLAY PANEL – 0.125 oz. packet
PRINCIPAL DISPLAY PANEL – 4 oz. bottle NDC 61010-5000-1 Safetec First Aid Burn Gel For Temporary Pain Relief of Minor Burns 4 fl. oz. (118 ml) Reorder no. 50001 PRINCIPAL DISPLAY PANEL – 4 oz. bottle
Principal Display Panel - Pouch label Safetec Burn Gel 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 Principal Display Panel - Pouch label
Principal Display Panel - 144 Box label NDC 61010-5000-04 Safetec First Aid Burn Gel For Temporary Pain Relief of Minor Burns Reorder No. 50007 To reorder: Call: 1-800-456-7077 Fax: 716-895-2969 Online: www.safetec.com Principal Display Panel - 144 Box label
Principal Display Panel - 25 Box label NDC 61010-5000-5 Safetec First Aid Burn Gel For Temporary Pain Relief of Minor Burns 25 Packets Each Packet Net. Wt. 0.9gm Principal Display Panel - 25 Box label
Principal Display Panel – 10 Packet Box Label Safetec ® First Aid Burn Gel Quickly soothes pain caused by minor burns 10 Packets Each Packet Net. Wt. 0.9g Made in USA Reorder No. 50028 Principal Display Panel – 10 Packet Box Label
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.Pain Relief 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
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 worsens or persists for more than 7 days or clears up and occurs again within a few days
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 doctor if condition worsens or persists for more than 7 days or clears up and occurs 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