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| Product NDC Code | 61010-5200 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Antiseptic |
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| Type | Brand | ||||||||||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||
| RxCUI drug identifier | 1190560 | ||||||||||||||
| Application Number | M003 | ||||||||||||||
| Labeler Name | Safetec of America, Inc. | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Ethyl alcohol 50.0% Lidocaine HCl 2.0%
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 adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. children under 2 years of age: Consult a doctor. Inactive ingredients benzalkonium chloride, menthol, purified water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, menthol, 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 in minor scrapes and temporary relief of itching of insect bites
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Antiseptic alcohol, lidocaine hydrochloride BENZALKONIUM CHLORIDE MENTHOL, UNSPECIFIED FORM WATER ALCOHOL ALCOHOL LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 – mini pouch label Safetec Sting Relief Insect Bite Antiseptic and Pain Reliever Contents: 1 single-use, premoistened towelette Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com EXP. LOT PRINCIPAL DISPLAY PANEL – mini pouch label
PRINCIPAL DISPLAY PANEL – 150 count box Safetec NDC 61010-5200-4 Sting Relief Insect Bite Antiseptic and Pain Reliever Reorder No. 52004 Contents: 150 single-use, premoistened towelettes PRINCIPAL DISPLAY PANEL – 150 count box
PRINCIPAL DISPLAY PANEL – 2 fl. oz. bottle NDC 61010-5200-1 Safetec Sting Relief Insect Bite Antiseptic and Pain Reliever 2 fl. oz. (59.1 ml) Reorder No. 52001 Package Not Child Resistant PRINCIPAL DISPLAY PANEL – 2 fl. oz. bottle
Principal Display Panel – 25 Count Box Label NDC 61010-5200-7 Safetec Sting Relief Insect Bite Antiseptic and Pain Reliever Contents: 25 single-use, premoistened towelettes Principal Display Panel – 25 Count Box 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.Antiseptic towelette 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 over large areas of the body in eyes over raw or blistered areas
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 conditions worsen or persist for more than 7 days or clear up and occur again within a few days.
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 over large areas of the body in eyes over raw or blistered areas Stop use and ask doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days. 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