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Product NDC Code | 10129-081 | ||||||||||||
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Drug Name | Proguard hand sanitizer gel |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | GEL | ||||||||||||
RxCUI drug identifier | 581662 | ||||||||||||
Application Number | part333A | ||||||||||||
Labeler Name | Gingi-Pak, a division of Belport Co. | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl Alcohol 70% v/v. 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.Directions Dispense enough gel in your palm to cover all surfaces of hands and finger. Rub hands together vigorously until dry. Usage on children requires adult supervision, not recommended for infants. Work best on clean and dry hands.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Distilled Water, Glycerin, Carbomer 940, Benzophenone-4, Aloe Vera, Aminomethyl Propanol.
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 Reduce bacteria that potentially can cause disease. Recommened 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.ProGuard Hand Sanitizer Gel Ethyl Alcohol ALCOHOL ALCOHOL SULISOBENZONE WATER GLYCERIN AMINOMETHYLPROPANOL ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
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 ProGuard Hand Sanitizer Gel 10129-081-02 ProGuard Hand Sanitizer Gel 10129-081-08 ProGuard Hand Sanitizer Gel 10129-081-16 ProGuard Hand Sanitizer Gel 10129-081-01 Single Use outer Single Use inner
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 around eyes in children less than 2 month of age on open skin wounds
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. If swallowed, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When Using This Product Keep out of eyes, ears, and mouth. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store below 43 C (110F) 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 For external use only: hands. Flammable. Keep away from heat or flame.
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