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| Product NDC Code | 64709-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Benzalkonium chloride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Diamond Wipes 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%
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 ■peel back label ■remove and unfold wipe ■wipe hands thoroughly ■dispose of used wipe in trash, do not flush
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Benzoate, 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 hand sanitizing to decrease bacteria on 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.Benzalkonium Chloride Antibacterial Wet Wipes WATER SODIUM BENZOATE GLYCERIN CITRIC ACID MONOHYDRATE HAMAMELIS VIRGINIANA TOP PHENOXYETHANOL ALOE VERA LEAF POTASSIUM SORBATE .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 20 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.Label Do Not Flush MADE IN U.S.A. WITH GLOBAL COMPONENTS Wipessentials ® WET WIPES 30 WIPES ANTIBACTERIAL 99.9% EFFECTIVE against most common germs* Peel & Reseal • Cleans without soap or water • With aloe and vitamin E • No added alcohol, triclosan and paraben • Fresh scent 30 WIPES 7" x 6" (17.7 cm x 15.2 cm) *Escherichia coli, Staphylococcus aureus, Salmonella typhimurium, Pseudomonas aeruginosa, Burkholderia cepacia, Enterobacter cloacae, Enterococcus faecalis, Streptococcus pyogenes, Candida albicans, Aspergillus brasiliensis Wipessentials ® Antibacterial Wet Wipes are proudly made in the USA with Global Components. Antimicrobial formula cleanses your hands without soap or water, 99.9% EFFECTIVE against most common germs* Formula with Aloe Vera, Vitamin E and Glycerin is gentle and helps moisturize and condition your skin. Made in USA with global components Diamond Wipes Int'l, Inc. Chino, CA 91710 1 (877) 871-1681 for comments www.diamondwipes.com ©2022 Diamond Wipes Int'l Drug Facts Active ingredient Purpose Benzalkonium Chloride 0.13% ............. Antimicrobial Uses ■for hand sanitizing to decrease bacteria on skin 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 Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away Directions ■peel back label ■remove and unfold wipe ■wipe hands thoroughly ■dispose of used wipe in trash, do not flush Inactive ingredients Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Tocopheryl Acetate, Water Item # F3988PCH30 7 66670 03988 6 PL-3988-6 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 Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away
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