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Foamfresh antibacterial hand wash - Medication Information

Product NDC Code 11429-1005
Drug Name

Foamfresh antibacterial hand wash

Type Brand
Active Ingredients
Chloroxylenol 2.5 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1356502
Application Number part333A
Labeler Name Woodbine Products Company
Packages
Package NDC Code Description
11429-1005-0 1125 ml in 1 bottle (11429-1005-0)
11429-1005-1 59 ml in 1 bottle, plastic (11429-1005-1)
11429-1005-2 250 ml in 1 bottle, plastic (11429-1005-2)
11429-1005-3 1000 ml in 1 bottle, plastic (11429-1005-3)
11429-1005-4 2125 ml in 1 bottle, plastic (11429-1005-4)
11429-1005-5 3785 ml in 1 bottle, plastic (11429-1005-5)
11429-1005-6 1500 ml in 1 bottle, plastic (11429-1005-6)
11429-1005-7 750 ml in 1 bottle, plastic (11429-1005-7)
11429-1005-8 1250 ml in 1 bottle, plastic (11429-1005-8)
11429-1005-9 1100 ml in 1 bottle (11429-1005-9)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Chloroxylenol 0.25%

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: For maximum efficiency, pump foam into dry hands, lather vigorously for 30 seconds, rinse and dry.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient: Water, Sodium Lauryl Sulfate, C10-16 Alkyl Glucoside, Cocamidopropyl Betaine, Lauryl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol, Fragrance and FDC Blue #1, FDC Yellow #5, FDC Yellow #6.

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 washing 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.
FoamFresh Antibacterial Hand Wash CHLOROXYLENOL WATER SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE LAURYL GLUCOSIDE DMDM HYDANTOIN PROPYLENE GLYCOL FD&C BLUE NO. 1 FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 CHLOROXYLENOL CHLOROXYLENOL

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.
FoamFresh Antibacterial Hand Wash The easiest way to clean hands. A fragranced, luxuriant foam, it is easily dispensed for an enjoyable hand wash. Sense the difference. Woodbine Products Company 915 West Smith Road Medina, OH 44256 www.woodbineproducts.com Made in USA Stock #4510 1000 ml. (34 fl. oz.) FoamFresh Antibacterial Fortified with Collagen container label

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. Children must be supervised in use of this product. 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 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. In case of eye contact, flush eyes with water.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information: Store at 20 to 25 C. (68 to 77 F)

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, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. Children must be supervised in use of this product. 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