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Product NDC Code | 11429-1001 | ||||||||||||||||
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Drug Name | Foamfresh alco-free hand sanitizer |
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Type | Brand | ||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||
Dosage Form | LIQUID | ||||||||||||||||
RxCUI drug identifier | 1038799 | ||||||||||||||||
Application Number | part333A | ||||||||||||||||
Labeler Name | Woodbine Products Company | ||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzalkonium Chloride 0.1%
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, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance.
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.FoamFresh Alco-Free Hand Sanitizer BENZALKONIUM CHLORIDE WATER CETRIMONIUM CHLORIDE LAURTRIMONIUM CHLORIDE DIHYDROXYETHYL COCAMINE OXIDE GLYCERETH-17 COCOATE CITRIC ACID MONOHYDRATE 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.FoamFresh Alco-Free Hand Sanitizer Formulated to reduce the number of germs on the hands that can cause infection and illness Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere Use on clean, non-soiled hands any time when rinsing with water is not available Kills 99.99% of common germs that can cause disease PK Woodbine Products Company 915 West Smith Road Medina, Ohio 44256 wwww.woodbineproducts.com Made in the U.S.A. Stock # 4350 1000 ml (34 fl. oz.) 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 conditions 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.
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 conditions 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