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Product NDC Code | 0924-5250 | ||||||
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Drug Name | First aid only sting relief |
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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 | 1037117 | ||||||
Application Number | M017 | ||||||
Labeler Name | Acme United Corporation | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzocaine 20 percent Menthol 1 percent
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 If stinger is present, remove carefully if possible. Adults Reverse cardboard sleeve so swab is visible. With cardboard sleeve on ampile, crush at dot on sleeve. There will be a "pop" and the swab will become saturated. Apply saturated applicator to the affected area no more than 3 to 4 times daily. Children under 2 Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.D&C Green no. 5, D&C yellow no.10, FD&C blue no.1, isopropyl alcohol, polyethylene glycol 300, 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.Uses For temporary relief of the pain and itching of •insect bites and stings •minor scrapes and burns
Purpose
Information about the drug product’s indications for use.Topical Analgesic Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.First Aid Only Sting Relief Benzocaine ISOPROPYL ALCOHOL WATER D&C GREEN NO. 5 D&C YELLOW NO. 10 FD&C BLUE NO. 1 POLYETHYLENE GLYCOL 300 BENZOCAINE BENZOCAINE MENTHOL MENTHOL
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.BOX19001-revD (002).jpg Sting Swabs Carton Image
First Aid Only Sting Relief: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other Information Store at room temperature.
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 the reach of children If swallowed, contact Poison Control 800.222.1222, or a doctor immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 800.835.2263
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 the eyes •if you are allergic to any of the ingredients Stop use and ask a doctor if •conditions worsen •symptoms clear up and then recur •the condition persists for more than 7 days
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