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| Product NDC Code | 60913-031 | ||||
|---|---|---|---|---|---|
| Drug Name | Sting and bite |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 1043353 | ||||
| Application Number | M003 | ||||
| Labeler Name | PHOENIX HEALTHCARE SOLUTIONS, 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 Benzocaine, 6% w/v
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, apply to affected area not more than 3-4 times daily. For children under 2 years of age, consult a doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Isopropyl Alcohol, Purified 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.Use For temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes and insect bites or minor skin irritations.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Sting and Bite Benzocaine WATER ISOPROPYL ALCOHOL BENZOCAINE BENZOCAINE
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 NDC 60913-031-01 Phoenix Healthcare Solutions, LLC "An Innovative Medical Manufacturer" Sting and Bite Pads Medium For Individual,Professional and Hospital Use Saturated with 6% Benzocaine as a topical analgesic Latex Free 100 Individual Pads Label
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 With electrocautery procedures.
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.Caution: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 If irritation and redness develop.If condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days,discontinue use and consult a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 15 0 -30 0 C (59 0 - 86 0 F). Avoid excessive heat.
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, keep away from fire or flame Avoid contact with eyes; if this happens, rinse thoroughly with water Do Not Use With electrocautery procedures. Stop Use If irritation and redness develop.If condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days,discontinue use and consult a doctor. Caution: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