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| Product NDC Code | 67777-246 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Benzocaine |
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| Type | Generic | ||||||
| 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 | 895749 | ||||||
| Application Number | M003 | ||||||
| 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, 6% w/v
Active Ingredient Isopropyl Alcohol, 60% 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. Children under 2 years: Consult a physician before use For other uses: Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients 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(s) For the temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Benzocaine Benzocaine ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER 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 Sting & Bite Pad Label 1408 DM Master
Label 1408UB-10 1408UB-10 1408UB-10_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 between 15º-30ºC (59º-86ºF) • Avoid excessive heat
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-396-2739 Monday - Friday 9AM-5PM EST.
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 • Condition worsens or symptoms persists for more than 7 days, or clear up and occur again within a few days, discontinue use and consult 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 • Flammable, keep away from fire or flame • Avoid contact with eyes; if this occures, rinse thoroughly with water • Do not use with electrocautery procedures Stop use if • Irritation and redness develop • Condition worsens or symptoms persists for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor 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