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Product NDC Code | 66608-056 | ||||
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Drug Name | Hand sanitizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1860080 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Kimball Midwest | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Section Active Ingredient Ethyl Alcohol 62% v/v
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 and Administration Directions Apply a small amount to palm. Briskly rub, covering hands with product until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Section Inactive Ingredients Water, Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Aminomethylpropanol
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 and Usage Section Uses For hand cleaning to decrease bacteria on skin.
Purpose
Information about the drug product’s indications for use.Purpose Section Purpose Antibacterial Agent
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer 62% Ethyl Alcohol .ALPHA.-TOCOPHEROL ACETATE, D- ISOPROPYL MYRISTATE GLYCERIN ALCOHOL ALCOHOL AMINOMETHYLPROPANOL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL 1,2-DISTEARATE ALOE VERA LEAF WATER
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 Label Principal Display Label
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 Section Keep Out Of Reach Of Children If swallowed, contact a physician or poison center.
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 Section Warnings For external use only. Flammable. Keep away from head or flame. Do not use in the eyes. In case of contact rinse thoroughly. Stop and ask a doctor if irritation and redness 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