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| Product NDC Code | 67777-405 | ||||
|---|---|---|---|---|---|
| Drug Name | Medicaine 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 | ||||
| Application Number | M017 | ||||
| Labeler Name | Dynarex Corporation | ||||
| 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 USP 20%
Active Ingredient L-Menthol USP 1%
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 Reverse cardboard sleeve then crush at dot between thumb and forefinger. Once solution has saturated tip, apply topically to the sting or bit. May be used on affected area(s) up to 4 times per day Not for use with children less than 2 years old without medical advise.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients D&C Green Dye #5, D&C Yellow Dye #10, FD&C Blue Dye #1, Isopropyl Alcohol, PEG 300 NF, Purified Water USP
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(s) For the temporary relief of pain and itching associated with insect bites and stings.
Purpose
Information about the drug product’s indications for use.Purpose Analgesic
Purpose Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Medicaine Sting and Bite Benzocaine MENTHOL 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.Label 1407 Medicaine Sting and Bite Ampule 1407 BX MASTER
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 (1-800-222-1222) 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 at room temperature 15º-30ºC (59º-86ºF) away from light.
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 persists, or if a rash, irritation, or allergic reaction develops.
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 Section • Do not use in the eyes • Not for prolonged use • Do not apply other medication to the same affected areas unless advised by a doctor
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 When Using Section • Do not use in the eyes • Not for prolonged use • Do not apply other medication to the same affected areas unless advised by a doctor Stop use and ask a doctor if Condition persists, or if a rash, irritation, or allergic reaction develops. Keep out of reach of children If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) 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