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Product NDC Code | 80976-100 | ||||||||||||
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Drug Name | Wipes4health |
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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 | Bubble Marketing Llc | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 hands thoroughly with product and allow to dry. • Children under six years of age should be supervised when using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).
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. • After changing diapers. • After assisting ill persons. • Before contact with a person under medical care or treatment. • Recommended for repeat 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.WIPES4HEALTH Benzalkonium Chloride WATER ALOE VERA LEAF POLYSORBATE 20 GLYCERIN POTASSIUM SORBATE CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS .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.Packaging Wipes 4 Health
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
Kills 99.99% of germs • Wet wipes clean and sanitize • Designed to use in health facilities, health clubs, schools, and wherever germs are present CAUTION: May irritate eyes. See side panel for further precautions and first aid instructions. Distributed by: Wipes 4 health P.O. Box 19121 • Topeka, KS 66619 Tel: 785.862.0340 • Fax: 785.862.0347 www.wipes4health.com DIRECTIONS FOR DISPENSING: Cut small "V" out of the bag. Pull the first towel from the center of the roll approximately 6 to 8 inches. Place bag in the dispenser and at the same time feed the first towel through the opening on the dispenser. DISPOSAL: Offer empty container for recycling. If recycling is not available, discard container in trash. Discard towel in trash after use. Do not flush. Made in China
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Store in a cool, dry place.
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. Do not use in the eyes. When using this product do not get into eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. 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