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| Product NDC Code | 58133-959 | ||||||||||||||||
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| Drug Name | Hand sanitizer |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | AEROSOL, SPRAY | ||||||||||||||||
| RxCUI drug identifier | 2286295 | ||||||||||||||||
| Application Number | part333A | ||||||||||||||||
| Labeler Name | Cosmetic Specialty Labs, Inc. | ||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient SD Alcohol 40 75%
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 Use enough product in your palm to cover hands and rub hands together biskly until dry. Children under 6 years of age should be supervised when using this product. Directions updated effective date to 05/03/2023
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Fragrance, Glycerin, Phenoxyethanol, Polysorbate-20, Purified Water, Tocopheryl Acetate.
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 Hand Sanitizer to help reduce bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer ALCOHOL POLYSORBATE 20 PHENOXYETHANOL WATER ALPHA-TOCOPHEROL ACETATE CAPRYLYL GLYCOL GLYCERIN ALOE VERA LEAF 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.Package Label Outer box outer box_959_71
Package Label Refill bottle 6oz refill NDC: 58133-959-68
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions updated effective date to 05/03/2023
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 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 rash appears and lasts.
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 or near the eyes. In case of contact, rinse eyes thoroughtly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store below 110F (43C) May discolor fabrics or surfaces
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 Flammable. Keep away from fire or flame. For external use only.
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