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Hand sanitizer - Medication Information

Product NDC Code 83986-370
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol 70 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581662
Application Number 505G(a)(3)
Labeler Name UpLift Brands LLC
Packages
Package NDC Code Description
83986-370-34 236 ml in 1 bottle, pump (83986-370-34)
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Adverse reactions

Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
Adverse reaction Dist. by: Vi-Jon, LLC St. Louis, MO 63114

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Ethyl alcohol 70%

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 allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

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 to decrease bacteria on the skin that could cause disease 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.
Hand Sanitizer Alcohol WATER GLYCERYL CAPRYLATE/CAPRATE GLYCERIN ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SULISOBENZONE ALCOHOL ALCOHOL

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 germ-X ® since 1997 ADVANCED KILLS MORE THEN 99.99% OF GERMS* moisturizing HAND SANITIZER USP GRADE ALCOHOL Fomulated for Healthcare Workers FORMULA MADE IN USA EMPLOYEE-OWNED 8FL OZ (236 mL) image description

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.
Claims *Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds. FORMULA MADE IN USA EMPLOYEE-OWNED

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information do not store above 105⁰F may discolor some fabrics harmful to wood finishes and plastics

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if skin irritation or redness develops condition persists for more than 72 hours

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. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest

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 and 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