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Product NDC Code | 66949-129 | ||||
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Drug Name | Zep round one ab |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Zep Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Chloroxylenol 0.4%
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 with water. Place hands under dispenser and apply liquid soap. Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles. Rinse hands thoroughly and dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Sodium C14-16 Olefin Sulfonate, Pumice, Cocamidopropyl Hydroxysultaine, Stearic Acid, Methacrylic Acid Copolymer, Attapulgite, C11-13 Pareth-6, PEG-75 Lanolin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Glutaral, Titanium Dioxide, Palmitostearic Acid, Orange 7, Yellow 5
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 Hand washing to decrease bacteria on skin
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic Handwash
Spl product data elements
Usually a list of ingredients in a drug product.ZEP ROUND ONE AB Chloroxylenol METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A C11-13 PARETH-6 TITANIUM DIOXIDE CHLOROXYLENOL CHLOROXYLENOL PALMITOSTEARIC ACID METHYLISOTHIAZOLINONE ATTAPULGITE WATER SODIUM C14-16 OLEFIN SULFONATE PUMICE PEG-75 LANOLIN METHYLCHLOROISOTHIAZOLINONE GLUTARAL COCAMIDOPROPYL HYDROXYSULTAINE DIPOTASSIUM 4',5'-DIBROMOFLUORESCEIN FD&C YELLOW NO. 5 STEARIC ACID
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.129_3094
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Do not use in or around the eyes.
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 Keep out of reach of children except under adult supervision.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Do not freeze. Dispose in accordance with all applicable federal, state and local regulations.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-877-I-BUY-ZEP (1-877-428-9937)
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 Stop use and ask a doctor if skin irritation or redness 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 If eye contact occurs, rinse promptly and thoroughly with water. Do not swallow. If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.
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.
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