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Product NDC Code | 55550-225 | ||||
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Drug Name | Antiseptic wipe |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Total Resources International | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzalkonium Chloride 0.13% w/w
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 remove and unfold wipe wipe hands thoroughly and allow hands to air dry do not flush
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Citric Acid, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water
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
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.ANTISEPTIC WIPE BENZALKONIUM CHLORIDE WIPE GLYCERIN WATER POLYSORBATE 20 HAMAMELIS VIRGINIANA LEAF ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE ANHYDROUS CITRIC ACID BENZALKONIUM CHLORIDE BENZALKONIUM PHENOXYETHANOL Cloth
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.Label ANTISEPTIC WIPE BE SMART GET PREPARED KILLS 99.9% OF GERMS ALOE VERA VITAMIN E ANTIBACTERIAL 1 PC, Pre- moistened Wipe, SINGLE USE Made in USA Manufactured for: TOTAL RESOURCES INTL. Walnut, California 91789 00-TOW-94186 Rev.00 NDC# 55550-225-11 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 Keeo out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature
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 avoid contact with eyes. If in eyes flush thoroughly with water Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours
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