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Product NDC Code | 61010-8600 | ||||
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Drug Name | Saniwash antimicrobial foaming hand |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 413262 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Safetec of America, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Chloroxylenol (PCMX)
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 and forearms. Apply 5 millimeters (teaspoonful) or palmful to hand and forearm. Scrub thoroughly for 30 seconds. Rince and repeat.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, calblend clear surfactant blend, DMDM hydantoin, fragrance, propylene glycol, purified/deionized water, tetrasodium EDTA, vitamin E acetate
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. Recommended for repeated use
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Saniwash Antimicrobial Foaming Hand Chloroxylenol ALOE VERA LEAF SODIUM LAURETH-3 SULFATE COCO DIETHANOLAMIDE COCAMIDOPROPYL BETAINE DMDM HYDANTOIN PROPYLENE GLYCOL WATER EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE 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.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL -18.6 fl. oz NDC 61010-8600-1 Safetec Saniwash Antimicrobial Foaming Hand Soap Effective against germs Cleans dirty hands yet gentle on skin Mild pleasant fragrance with Aloe Manufactured by Safetec Safetec of America, Inc Buffalo, NY 14215 1-800-456-7077 www.safetec.com Reorder No. 34456 Net Contents 18.6 fl. Oz (550 ml) PRINCIPAL DISPLAY PANEL -18.6 fl. oz
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 doctor if irritation or redness develop and 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 supervise children under 6 do not use in eyes. If contact occurs, rinse 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 supervise children under 6 do not use in eyes. If contact occurs, rinse thoroughly with water. Stop use and ask doctor if irritation or redness develop and persists 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