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Product NDC Code | 77267-004 | ||||||||||||
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Drug Name | Anti-bacterial hand sanitizer gel |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | GEL | ||||||||||||
RxCUI drug identifier | 1305100 | ||||||||||||
Application Number | 505G(a)(3) | ||||||||||||
Labeler Name | NingboRiwayIndustrialCo.,Ltd. | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Ethyl Alcohol 75%.
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 Squeeze the bottle after removing the lid and thoroughly spread on both hands. Rub into skin until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water,Glycerin, Aloe barbadensis leaf extract,Carbomer,Tocopheryl Acetate,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.Use Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use.
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.Anti-Bacterial Hand Sanitizer Gel Ethyl Alcohol .ALPHA.-TOCOPHEROL ACETATE GLYCERIN ALOE VERA LEAF WATER ALCOHOL ALCOHOL TROLAMINE CARBOMER COPOLYMER TYPE A
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 - Principal Display Panel label-30ml label-60ml label-100ml label-500ml label-1000ml
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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. Children must be supervised in use of this product.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 20 °C(88 to 77°F) may discolor fabrices.
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 or flame. Do not apply around eyes. Do not use in ears & mouth. When using this product, avoid contact with eyes. In case of contact flush eyes with water. Stop use and ask a doctor it redness or irritation develop and persist for more than 72 hours.
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