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Foaming hand sanitizer - Medication Information

Product NDC Code 83986-118
Drug Name

Foaming hand sanitizer

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form LIQUID
Application Number 505G(a)(3)
Labeler Name UpLift Brands LLC
Packages
Package NDC Code Description
83986-118-44 532 ml in 1 bottle, plastic (83986-118-44)
83986-118-45 1150 ml in 1 bottle, plastic (83986-118-45)
83986-118-86 1000 ml in 1 bottle, plastic (83986-118-86)
83986-118-96 221 ml in 1 bottle, plastic (83986-118-96)
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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 reactions DISTRIBUTED BY: UPLIFT BRANDS, LLC ST. LOUIS, MO 63114 1-866 MY GERMX

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzalkonium Chloride 0.13%

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 cetrimonium chloride, diglycerin, disodium cocoamphodiacetate, fragrance, glycerin, hydrochloric acid, methoxy PEG/PPG-7/3 aminopropyl dimethicone, sodium benzoate, tetrasodium EDTA, water

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 to decrease bacteria on the skin

Purpose

Information about the drug product’s indications for use.
Purpose Antibacterial

Spl product data elements

Usually a list of ingredients in a drug product.
Foaming Hand Sanitizer Benzalkonium Chloride CETRIMONIUM CHLORIDE DIGLYCERIN DISODIUM COCOAMPHODIACETATE GLYCERIN HYDROCHLORIC ACID METHOXY PEG/PPG-7/3 AMINOPROPYL DIMETHICONE SODIUM BENZOATE EDETATE SODIUM WATER BENZALKONIUM CHLORIDE BENZALKONIUM

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 ® PRO ALCOHOL FREE FOAMING HAND SANITIZER 1000 ML (1.05 QT) 33.8 FL OZ image description

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.

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 if irritation and 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 avoid contact with eyes. If contact occurs, rinse thoroughly with water. avoid contact with broken skin

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

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