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Product NDC Code | 20276-431 | ||||||||||||||||
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Drug Name | Wet wipes |
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Type | Brand | ||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||
Dosage Form | SWAB | ||||||||||||||||
RxCUI drug identifier | 1038856 | ||||||||||||||||
Application Number | part333A | ||||||||||||||||
Labeler Name | Delta Brands, Inc | ||||||||||||||||
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 • for adults and children 2 years and over use on hands and face to clean and refresh, allow skin to air dry. For children under 2 years of age ask a doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water, propylene glycol, cocamidopropyl betaine, peg-7 glyceryl cocoate, fragrance, benzyl alcohol, methylchloroisothiazolinine, methylisothiazolinone, tetrasodium EDTA, peg-40 hydrogenated castor oil, cetrimonium chloride, citric acid, aloe vera extract, alphatocopherol 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 •decreases bacteria on the skin
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.Wet Wipes Benzalkonium chloride WATER PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE EDETATE SODIUM CETRIMONIUM CHLORIDE CITRIC ACID MONOHYDRATE ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE 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.Package Label Package Label
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 •Over large areas of the body if you are allergic to any of the ingredients
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. 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 Stop use and ask a doctor if irritation or rash develops and continues 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 •do not get into 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
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