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Babyganics alcohol-free foaming hand sanitizer - Medication Information

Product NDC Code 59062-3001
Drug Name

Babyganics alcohol-free foaming hand sanitizer

Type Brand
Active Ingredients
Benzalkonium chloride .12 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1046310
Application Number part333E
Labeler Name KAS Direct LLC dba BabyGanics
Packages
Package NDC Code Description
59062-3001-1 473 ml in 1 bottle, pump (59062-3001-1)
59062-3001-2 250 ml in 1 bottle, pump (59062-3001-2)
59062-3001-5 50 ml in 1 bottle, pump (59062-3001-5)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzalkonium chloride 0.12%

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 pump a small amount of foam into palm of hand rub thoroughly over all surfaces of both hands rub hands together briskly until dry

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, propanediol, cocamidopropylamine oxide, cetrimonium chloride, pyrus malus (apple) fruit extract, aloe barbadensis leaf juice Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic. , calendula officinalis flower extract , chamomilla recutita (matricaria) flower extract , olea europaea (olive) leaf extract , glycerin, citric acid

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 for hand sanitizing to decrease bacteria on the skin recommended for repeated use

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
BabyGanics Alcohol-Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER PROPANEDIOL COCAMIDOPROPYLAMINE OXIDE CETRIMONIUM CHLORIDE APPLE ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER CHAMOMILE OLIVE OIL GLYCERIN CITRIC ACID MONOHYDRATE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE

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 - 249 mL Bottle Label babyganics ® alcohol-free foaming hand sanitizer fragrance free kills 99.9% of bacteria* dermatologist tested Discover which of our ingredients are certified organic on the back panel. 8.45 FL OZ (249 mL) 1137400 Principal Display Panel - 249 mL Bottle Label

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. 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 irritation or redness develops, or if condition lasts 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. In case of eye contact, rinse eyes thoroughly with water.

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 When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or redness develops, or if condition lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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