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Moisturizing antibacterial - Medication Information

Product NDC Code 62440-279
Drug Name

Moisturizing antibacterial

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 g/ml
Route TOPICAL
Dosage Form SOAP
Application Number 505G(a)(3)
Labeler Name Swinton Avenue Trading Ltd.Inc.
Packages
Package NDC Code Description
62440-279-68 1680 ml in 1 bottle, plastic (62440-279-68)
62440-279-96 221 ml in 1 bottle, pump (62440-279-96)
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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 For questions or comments, please call-1866-795-8481 Distributed by: Swinton Avenue Trading Ltd., Inc,. 6600 N. Military Trail Boca Raton, FL 33496 USA Highnark is a trademark or registered trademark of OMX, Inc. 2018 Office Depot, Inc. All Rights Reserved Made in USA with US and foreign components

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzalkonium chlroide 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 apply palmful to hands scrub thoroughly rinse thoroughly

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 33, red 40, yellow 5

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 for handwashing 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.
Moisturizing Antibacterial Benzalkonium chloride 0.13% WATER LAURAMINE OXIDE COCAMIDOPROPYL BETAINE LAURAMIDOPROPYLAMINE OXIDE SODIUM CHLORIDE MYRISTAMIDOPROPYLAMINE OXIDE GLYCERIN DISTEARETH-75 ISOPHORONE DIISOCYANATE PEG-150 DISTEARATE CITRIC ACID MONOHYDRATE EDETATE SODIUM SULISOBENZONE SODIUM BENZOATE D&C RED NO. 33 FD&C RED NO. 40 FD&C YELLOW NO. 5 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 HIGHMARK ANTBACTERIAL HAND SOAP economical refill size Compare to Softsoap Crisp Clean Antibacterial Hand Soap with Moisturizers* LIGHT MOISTURIZING 56 FL OZ (1.65 L) 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.
disclaimer *This product is not manufactured or distributed by Colgate-Palmolive Company, distributor of Softsoap Crisp Clean Antibacterial Hand Soap with Moisturizers. For questions or comments, please call 1-866-795-8481. Distributed by: Swinton Avenue Trading Ltd. Inc. 6600 N. Military Trail, Boca Raton, FL 33496 USA Highmark is a trademark or registrademark of OMX, Inc. (c) 2015 Office Depot, Inc. All rights reserved. Made in USA with US and foreign components

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 1-866-795-8481

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

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 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-hands only

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