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| Product NDC Code | 81907-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Nasalguard antiseptic topical cool menthol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1098199 | ||||
| Application Number | part333E | ||||
| Labeler Name | TRUTEK CORP. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzalkonium Chloride 0.13%
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 Apply to the outside of the nose as indicated below. Begin by squeezing 1 to 2 pin-sized drops on your pointer finger. Spread the gel between your pointer finger and thumb to ensure an even application. Apply directly around the nostrils and above the upper lip. Apply every 4 to 6 hours or as often as needed. Reapply if nose or face becomes wet. SAVE THIS (BOX) FOR REFERENCE
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Dimethicone, Glycerin, Hydroxyethyl Cellulose, Purified Water. Alson contains non-toxic, cosmetic grade preservatives and emulsifiers.
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 To decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.NasalGuard Antiseptic Topical Cool Menthol Benzalkonium Chloride DIMETHICONE 350 STEARETH-2 MENTHOL WATER MEDIUM-CHAIN TRIGLYCERIDES BENZALKONIUM CHLORIDE BENZALKONIUM HYDROXYETHYL CELLULOSE, UNSPECIFIED STEARETH-21 GLYCERIN PHENOXYETHANOL POTASSIUM SORBATE BEHENTRIMONIUM CHLORIDE
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.TUBE AND CARTON FOR MENTHOL NASALGUARD TUBE ART BOX ART
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.WARNINGS - NO MAJOR CHANGES. I just saved incomplete, then went in again to complete. INDICATIONS AND USAGE - Only a date change, not major. DOSAGE AND ADMINISTRATION - Only a date change, not major.
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments ? Visit www.NasalGuard.com or call 1-855-NASALGUARD (1-855-627-2548).
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 a doctor if irritation and redness develop or condition persists for more than 72 hours
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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.For external use only When using this product keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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