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| Product NDC Code | 61010-1122 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Saniwash antimicrobial |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| 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 ingredients Chloroxylenol (PCMX) 0.6%
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 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, 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 handwashing 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 Chloroxylenol ALOE VERA LEAF SODIUM LAURETH-3 SULFATE COCO DIETHANOLAMIDE COCAMIDOPROPYL BETAINE PROPYLENE GLYCOL PROPYLPARABEN METHYLPARABEN DIAZOLIDINYL UREA WATER SODIUM CHLORIDE 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 - 1 GALLON BOTTLE NDC 61010-1122-6 Safetec SaniWash Antimicrobial Hand Soap Effective against germs Cleans dirty hands yet gentle on skin Mild pleasant fragrance with Aloe Reorder No. 34455 NET CONTENTS 1 gal (3.785 L) PRINCIPAL DISPLAY PANEL - 1 GALLON BOTTLE
PRINCIPAL DISPLAY PANEL - 800 mL Bag-In-Box Manufactured by Safetec Safetec of America, Inc. Buffalo, NY 14215 1-800-456-7077 www.safetec.com Reorder No. 34465 NDC 61010-1122-4 27.05 fl. oz. (800 ml.) SaniWash Antimicrobial Hand Soap PRINCIPAL DISPLAY PANEL - 800 mL Bag-In-Box
PRINCIPAL DISPLAY PANEL - 16 oz. BOTTLE NDC 61010-1122-3 SaniWash Antimicrobial Hand Soap Effective against germs Cleans dirty hands yet gentle on skin Mild pleasant fragrance with Aloe NET CONTENTS 16 fl. oz. (473 ml) Safetec Reorder No. 34452 PRINCIPAL DISPLAY PANEL - 16 oz. BOTTLE
Principal Display Panel - Bottle Label NDC 61010-1122-7 Safetec SaniWash ® Antimicrobial Hand Soap Effective against germs Cleans dirty hands yet gentle on skin Mild pleasant fragrance with Aloe NET CONTENTS 55 gal (208.2 L) Reorder No. 34457 Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com Principal Display Panel - 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
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 a doctor if irritation or redness develop and persist 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 the 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 the eyes. If contact occurs, rinse thoroughly with water Stop use and ask a doctor if irritation or redness develop and persist 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