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| Product NDC Code | 84456-746 | ||||
|---|---|---|---|---|---|
| Drug Name | Saniiswab |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 1041780 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | POLLEY MED LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Alcohol 62%. Purpose: 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.Adults and children over 12 years of age Step 1. Cleaning. Open Step 1 packet and hold handle, inserting one swab tip into each nostril. Swab lower interior skin inside the nose in a circular motion 7 times. Handle guard protects against insertion of swab tip beyond the nostrils. Discard. Step 2. Sanitizing. Repeat Step 1 with Step 2 packet. Discard. Adults and children 12 years and over- Use once a day Children under 12 years of age- Use under adult supervision Children under 5 years- Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, glycerin, sodium chloride, sodium benzoate, PEG-60 hydrogenated castor oil, cocamidopropyl betaine, lavender oil
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.Two-step method to clean and sanitize the skin of the lower inner nostrils ■ cleans ■ sanitizes
Purpose
Information about the drug product’s indications for use.Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.SaniiSwab ethyl alcohol COCAMIDOPROPYL BETAINE WATER ALCOHOL ALCOHOL GLYCERIN LAVENDER OIL SODIUM CHLORIDE SODIUM BENZOATE PEG-60 HYDROGENATED CASTOR OIL
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.Package label
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 or mouth More than twice a day If product is opened or damaged If you are allergic to any ingredients If you have a history of nasal irritation or bleeding Stop use and ask a doctor if redness, pain, or irritation appear and lasts more than 24 hours. Keep out of reach of children.
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.
Storage and handling
Information about safe storage and handling of the drug product.Protect from excessive moisture Avoid freezing and excessive heat above 40 °C (104 °F)
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.Flammable, keep away from fire and flames For external use only
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