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Product NDC Code | 82140-432 | ||||||||
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Drug Name | Stayklear |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LIQUID | ||||||||
Application Number | 505G(a)(3) | ||||||||
Labeler Name | eHealth Nexus LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl Alcohol 63% by volume
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: Wet hands thoroughly with product and rub hands together, palms, backs and nails and wrists, until dry, without wiping. Children under 6 years of age should be supervised when using this product. Directions Wet hands thoroughly with product and rub hands together, palms, backs and nails, until dry, without wiping. Children under 6 years of age should be supervised when using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, glycerin, propylene glycol, sodium salicylate, panthenol,‡ sodium lauryl sulfate, salicylic acid, hydroxypropyl cellulose, lactic acid, niacinamide,** isopropyl myristate, fragrance, copper gluconate, benzoic acid, orange oil, adipic acid, acetic acid, glycine, sodium chloride. **Vitamin B3, ‡Pro-vitamin B5
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 Antiseptic rub and hand sanitizer to help reduce bacteria and viruses on skin that could cause disease. For use when soap and water are not available.
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.STAYKLEAR ALCOHOL VANILLIN BENZYL BENZOATE ISOPROPYL MYRISTATE LACTIC ACID WATER ALCOHOL ALCOHOL HYDROXYPROPYL CELLULOSE, UNSPECIFIED PANTHENOL PROPYLENE GLYCOL SODIUM SALICYLATE GLYCERIN SODIUM LAURYL SULFATE NIACINAMIDE ADIPIC ACID BENZOIC ACID SALICYLIC ACID GLYCINE COPPER GLUCONATE ACETIC ACID SODIUM CHLORIDE ORANGE 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 StayKlear Label 01 3.4 oz StayKlear 2023-04-05 2
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.Directions Wet hands thoroughly with product and rub hands together, palms, backs and nails, until dry, without wiping. Children under 6 years of age should be supervised when using this product.
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store below 110° F (43 C). •Dried product may turn brown from copper oxide. •May discolor certain fabrics or surfaces.
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: Flammable. Keep away from fire and flame. For external use only. Do not ingest. When using this product, do not use in or near eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor, if irritation or rash appears and lasts.
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