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Product NDC Code | 67777-320 | ||||
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Drug Name | Sannytize hand sanitizer wipe |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1489307 | ||||
Application Number | part333A | ||||
Labeler Name | Dynarex Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Active Ingredient Purpose Ethyl Alcohol 70% Antiseptic Wipe
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.DOSAGE & ADMINISTRATION Wet hands thoroughly with product and allow to dry without wiping.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Inactive ingredients: Water, Glycerin, Propylene glycol, Diazolidinyl urea, Aloe barbadensis leaf juice, Polysorbate 20, Carbomer, Tocopherol acetate, Methylparaben, Propylparaben, Triethanolamine
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.INDICATIONS & USAGE For hand washing to decrease bacteria on the skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.PURPOSE Antiseptic handwash
Spl product data elements
Usually a list of ingredients in a drug product.SannyTize Hand Sanitizer Wipe Alcohol WATER GLYCERIN PROPYLENE GLYCOL ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 20 DIAZOLIDINYL UREA PROPYLPARABEN METHYLPARABEN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALCOHOL ALCOHOL TROLAMINE
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 Dynarex SannyTizer HandSanitizing Wipes Sannywipe.jpg 1306 IN Master
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.- Content of Labeling - Indications and Usage Section - Date Incorporated 09/2020 - Content of labeling - Dosage and Administration Section - Date incorporated 09/2020
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 KEEP OUT OF REACH OF CHILDREN, if swallowed get medical help or contact a Poison Control Center right away.
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 and flame When using this product avoid contact with eyes. In case of eye contact, rinse with water to remove. Stop use and ask a doctor if irritation and redness develops
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