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Product NDC Code | 62654-140 | ||||||||||||||||
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Drug Name | Dermacen instant hand sanitizer |
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Type | Brand | ||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||
Dosage Form | LIQUID | ||||||||||||||||
RxCUI drug identifier | 1100016 | ||||||||||||||||
Application Number | part333A | ||||||||||||||||
Labeler Name | Central Solutions Inc | ||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Ethanol 64.5% (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 Wet hands thoroughly with product. Allow to dry without wiping. Use no water or towels.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Tetrahydroxypropyl Ethylenediamine, 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 An antiseptic hand sanitizer for topical application Prevents infection and cross contamination Reduces transient microorganisms on intact skin Keep hands from drying due to repeated uses
Purpose
Information about the drug product’s indications for use.Purpose Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.DermaCen Instant Hand Sanitizer Alcohol Alcohol Alcohol CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) EDETIC ACID GLYCERIN WATER
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.DermaCen Instant Hand Sanitizer For hand washing to decrease bacteria on the skin. Net Contents 8 ounces (236 ml) container 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. If swallowed, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Avoid contact with eyes In case of eye contact, flush with water for 15 minutes Discontinue use and see a doctor if irritation occurs Avoid contact with broken skin
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.Other Information This product has not been tested on animals.
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 Flammable, keep away from fire or flame When using this product Avoid contact with eyes In case of eye contact, flush with water for 15 minutes Discontinue use and see a doctor if irritation occurs Avoid contact with broken skin 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