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Product NDC Code | 83913-001 | ||||
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Drug Name | Impactful cleaning disinfecting wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
RxCUI drug identifier | 1038558 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | IMPACTFUL BRANDS LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (s) Benzalkonium Chloride (0.13%)
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 targeted area thoroughly with product and let dry without wiping.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Purified Water, Phenoxyethanol, Ethylhexylglycerin, Didecylcimonium Chloride, Propylene Glycol, Glycerin, Ammonium Chloride.
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.Use (s) Specially designed for the following occassions: · Gym and Fitness Centers · Beauty Centers and Massage Therapy Spas. · Yoga & Dance Studios.
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.IMPACTFUL CLEANING DISINFECTING WIPES Wipes WATER PHENOXYETHANOL ETHYLHEXYLGLYCERIN PROPYLENE GLYCOL BENZALKONIUM CHLORIDE BENZALKONIUM DIDECYLDIMONIUM CHLORIDE GLYCERIN AMMONIUM CHLORIDE
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.NDC: 83913-001-01 Front Label Information 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 and pets.
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 usage if skin irritation occurs and consult a doctor, keep wipes inside the original packaging.
Storage and handling
Information about safe storage and handling of the drug product.Other information · Store below 104℉ (40°C). · Read the product label carefully before use.
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 · Keep out of reach of children and pets. · Dispose of product thoroughly. · Do not flush down the toilet. · Keep away from eyes. In case of contact with eyes, rinse immediately with plenty of water for several minutes. · Do not ingest. In case of ingestion, do not induce vomiting and consult a doctor immediately. · If you have hypersensitivity to any of the components of the formula, do not use the product. · Stop usage if skin irritation occurs and consult a doctor, keep wipes inside the original packaging.
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