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| Product NDC Code | 77955-001 | ||||
|---|---|---|---|---|---|
| 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 | 505G(a)(3) | ||||
| Labeler Name | Custom Chemical Solutions | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (v/v) 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: Pump enough product into palm of hand to thoroughly cover all surfaces of both hands. Rub hands together briskly until dry. For children under 6, use only under adult supervision.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water (Eau), Triisopropanolamine, Propylene Glycol, Acrylates/C10-30 Alkylate Crosspolymer, Glycerin, Fragrance (Parfum), Isopropyl Myristate, Tocopheryl Acetate, Denatonium Benzoat.
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 To decrease bacteria on the skin that could cause disease Recommended for repeated use
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.Hand Sanitizer Alcohol TRIISOPROPANOLAMINE ISOPROPYL MYRISTATE WATER .ALPHA.-TOCOPHEROL ACETATE DENATONIUM BENZOATE CARBOMER INTERPOLYMER TYPE A (55000 CPS) PROPYLENE GLYCOL GLYCERIN ALCOHOL ALCOHOL
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.HAND SANITIZER GEL UniFirst Corporation 88UC 1L (1000 mL, 33.8 US fl. oz.) container labelHSG1
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.
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 or redness develops, or if 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 avoid contact with eyes. In case of eye contact, flush eyes with water. Avoid contact with broken skin. Do not ingest or inhale.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store below 110 F (43 C). May discolor some fabrics. May be harmful to wood finishes and plastics.
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 avoid contact with eyes. In case of eye contact, flush eyes with water. Avoid contact with broken skin. Do not ingest or inhale. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. 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