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Product NDC Code | 78940-011 | ||||
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Drug Name | Health e wipes, lemon scent |
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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 | Golden Mills 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% Purpose Antiseptic
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 Tear V notch located on top of the plastic bag. Pull out the first wipe approximately 6 to 8 inches from the center of the roll. Place entire bag inside of center pull dispenser. Thread the wipe through the opening on the dispenser. Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up. Apply topically to the skin to help prevent cross contamination. Recommended for repeated use. Dries in seconds.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe barbadensis extract, diazolidinyl urea, fragrance, glycerin, lauryl betain, methylparaben/ethylparaben/propylparaben/butylparaben /isobutylparaben/phenoxyethanol, PEG-40 hydrogenated castor oil, propylene glycol, 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 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.Health E Wipes, Lemon Scent BENZALKONIUM CHLORIDE DIAZOLIDINYL UREA GLYCERIN LAURYL BETAINE METHYLPARABEN ETHYLPARABEN PROPYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN PHENOXYETHANOL POLYOXYL 40 HYDROGENATED CASTOR OIL PROPYLENE GLYCOL WATER 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 Labeling: 1000 Wipes Label02
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
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 unless under adult supervision
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 May irritate eyes Keep out of reach of children unless under adult supervision
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