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Softsoap antibacterial clean and protect cool splash - Medication Information

Product NDC Code 35000-254
Drug Name

Softsoap antibacterial clean and protect cool splash

Type Brand
Active Ingredients
Benzalkonium chloride 1.33 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1046593
Application Number part333E
Labeler Name Colgate-Palmolive Company
Packages
Package NDC Code Description
35000-254-11 332 ml in 1 bottle (35000-254-11)
35000-254-91 1470 ml in 1 bottle (35000-254-91)
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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 wash hands and rinse

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Citric Acid, Sodium Benzoate, PEG-120 Methyl Glucose Dioleate, Fragrance, Sodium Chloride, Tetrasodium EDTA, Blue 1, Red 33.

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 helps eliminate bacteria on hands

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.
Softsoap Antibacterial Clean and Protect Cool Splash Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER CETRIMONIUM CHLORIDE GLYCERIN LAURAMIDOPROPYLAMINE OXIDE COCO MONOETHANOLAMIDE ANHYDROUS CITRIC ACID SODIUM BENZOATE PEG-120 METHYL GLUCOSE DIOLEATE SODIUM CHLORIDE EDETATE SODIUM FD&C BLUE NO. 1 D&C RED NO. 33

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 - 332 mL Bottle Label Softsoap BRAND ANTIBACTERIAL clean & protect ELIMINATES 99.9% OF BACTERIA THAT CAN POTENTIALLY CAUSE DISEASE* ENRICHED WITH MOISTURIZERS cool splash ANTIBACTERIAL HAND SOAP 11.25 FL OZ (332 mL) PS0029919 PRINCIPAL DISPLAY PANEL - 332 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 DIST. BY: COLGATE-PALMOLIVE COMPANY, NEW YORK, NY 10022 USA

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, except under adult supervision. 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? 1-800-255-7552

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 contact, flush 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 contact, flush with water. Keep out of reach of children, except under adult supervision. 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