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| Product NDC Code | 61010-5300 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antiseptic |
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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 | SPRAY | ||||||
| RxCUI drug identifier | 1245229 | ||||||
| Application Number | M003 | ||||||
| Labeler Name | Safetec of America, Inc. | ||||||
| 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 Ingredients Benzalkonium Chloride 0.1% Benzocaine 5.0%
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 clean affected and spray 1 to 3 times daily may be covered with a sterile bandage children under 2 ask a doctor.
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.Uses First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic Topical Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Antiseptic benzalkonium chloride, benzocaine ISOPROPYL ALCOHOL WATER BENZALKONIUM CHLORIDE BENZALKONIUM 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 – bottle label NDC 61010-5300-0 Safetec Cut & Scrape Antiseptic Spray For Temporary Pain Relief and to Help Prevent Infection in Minor Cuts, Scrapes and Abrasions. 2 fl. oz. (59.1ml) Reorder no. 53000 PRINCIPAL DISPLAY PANEL – bottle 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
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 near eyes or mucous membranes on deep or puncture wounds, animal bites, or serious burns over large areas of the body more than one week unless directed by a doctor
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.
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 doctor if condition persists or gets worse
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 near eyes or mucous membranes on deep or puncture wounds, animal bites, or serious burns over large areas of the body more than one week unless directed by a doctor Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. Stop use and ask doctor if condition persists or gets worse
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