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| Product NDC Code | 81900-014 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Nasoclenz |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | GEL | ||||||||||
| Application Number | 505G(a)(3) | ||||||||||
| Labeler Name | Silicon Valley Innovations, 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 Ingredient Benzalkonium chloride (0.13%)
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.NasoClenz Cleansing Kit Drug Facts
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.Use every 4-8 hours as needed Children under age 12 use with adult supervision
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients - 81900-013 Carbomer, Diethylene Glycol Monoethyl Ether, Glycerin, Propylene Glycol, Triethanolamine, Water
Inactive Ingredients - 81900-014 Carbomer, Diethylene Glycol Monoethyl Ether, Glycerin, Peppermint Oil, Propylene Glycol, Triethanolamine, 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.Antiseptic preparation to decrease bacteria on skin
Purpose
Information about the drug product’s indications for use.Uses Helps reduce bacteria that can cause skin infections
Spl product data elements
Usually a list of ingredients in a drug product.NasoClenz Benzalkonium Chloride 0.13% PROPYLENE GLYCOL WATER GLYCERIN BENZALKONIUM CHLORIDE BENZALKONIUM DIETHYLENE GLYCOL MONOETHYL ETHER TROLAMINE CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) PEPPERMINT OIL NasoClenz Benzalkonium Chloride 0.13% BENZALKONIUM CHLORIDE BENZALKONIUM WATER TROLAMINE CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) DIETHYLENE GLYCOL MONOETHYL ETHER GLYCERIN PROPYLENE GLYCOL
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 - 81900-013 Drug Facts
Principal Display Panel - 81900-014 Drug Facts
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.Ask a doctor before use if you have Deep or puncture wounds Serious burns
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 If you are allergic to any of the ingredients In or near the eyes On children under 2 years of age
Instructions for use
Information about safe handling and use of the drug product.Directions Apply gel to tip of Cleansing Wand Insert tip with gel into nostril, rotating it in each direction several times Wipe any excess gel from nose with a tissue
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-844-4MY-NASO OR (1-844-469-6276) M-F 9am to 5pm PST NasoClenz.com
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, swelling, pain or other symptoms develop
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect from excessive heat (temperatures about 104°F/40°C)
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 ingest.
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