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Product NDC Code | 0924-5204 | ||||||||||||
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Drug Name | First aid only sting relief pad |
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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 | LIQUID | ||||||||||||
RxCUI drug identifier | 895749 | ||||||||||||
Application Number | part333A | ||||||||||||
Labeler Name | Acme United Corporation | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Benzocaine 6.0% Isopropyl Alcohol 60% w/v Purpose Topical Anesthetic Antiseptic
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 to 4 times daily ▪Children under 2 years: consult physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient 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.For the temporary relief of pain and itching associated with minor scrapes and insect bites. First aid to help prevent infection in minor cuts, scrapes, and burns.
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.First Aid Only Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL WATER BENZOCAINE BENZOCAINE ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL
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.pouch label Pouch 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.Drug Facts
Other information store at room temperature
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Consult a doctor ▪if condition worsens ▪if symptoms last for more than seven days or clear up and occur again ▪for deep puncture wounds
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 eyes, if contact occurs flush with water ▪over large areas of the body
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.
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 Do Not Use in eyes, if contact occurs flush with water ▪over large areas of the body Consult a doctor ▪if condition worsens ▪if symptoms last for more than seven days or clear up and occur again ▪for deep puncture wounds 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