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| Product NDC Code | 51706-904 | ||||
|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 581660 | ||||
| Application Number | part333A | ||||
| Labeler Name | Landy International | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) EthyI Alcohol 62%
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 without wiping■for children under 6, use only under adult supervision I not recommended for infants
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients WaterAqua), Glycerin, Acrylates/C10-30-alky| acrylate crosspolymer, Triethanolamine, Fragrance (Parfum), Tocopheryl acetate, Denatonium benzoate.
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.Use ■decreases bacteria on the skin that could cause disease ■recommended for repeated 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.Hand Sanitizer ALCOHOL DENATONIUM BENZOATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) GLYCERIN WATER ALCOHOL ALCOHOL TROLAMINE .ALPHA.-TOCOPHEROL ACETATE
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 Label - Principal Display Panel 1
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.
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: hands Flammable, keep away from fire or flame. When using this product■keep out of eyes. In case of contact with eyes flush thoroughly with water.■avoid contact with broken skin■do not inhale or ingest Stop use and ask doctor if■irrtation and redness develop m condition persists 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