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Product NDC Code | 50332-0040 | ||||||
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Drug Name | Hand sanitizer |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
Application Number | M | ||||||
Labeler Name | HART Health | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Ethyl 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 years of age; use only with adult supervision
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingrediends acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine
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 hanwashing to decrease bacteria on skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic handwash
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer Antiseptic Gel ALCOHOL ALCOHOL ALOE D&C GREEN NO. 5 D&C YELLOW NO. 10 TROLAMINE 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.5399HandSanitizerv21f.jpg
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. 1-800-222-1222
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours
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 do not use in the eyes in case of contact, rinse eyes throughly with water
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 heat and flame
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