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| Product NDC Code | 21749-713 | ||||||||||||||||||||||||||||||
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| Drug Name | Purell advanced soothing |
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| Type | Brand | ||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||||
| Dosage Form | GEL | ||||||||||||||||||||||||||||||
| RxCUI drug identifier | 581662 | ||||||||||||||||||||||||||||||
| Application Number | part333E | ||||||||||||||||||||||||||||||
| Labeler Name | GOJO Industries, Inc. | ||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl alcohol 70% v/v
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 Put enough product in your palm to cover hands and rub hands together briskly until dry Children under 6 years of age should be supervised when using PURELL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Blue 1 (CI 42090), Yellow 5 (CI 19140) Distributed by: GOJO Industries, Inc. Akron, OH 44309 Questions? Tel: 1-888-4-PURELL ￭ www.PURELL.com ©2011, GOJO Industries, Inc. All rights reserved. Made in U.S.A.
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 Hand sanitizer to help reduce bacteria on the skin
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.Purell Advanced Soothing alcohol ALCOHOL ALCOHOL WATER ISOPROPYL ALCOHOL ALOE VERA LEAF CAPRYLYL GLYCOL GLYCERIN ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE, D- AMINOMETHYLPROPANOL FD&C BLUE NO. 1 FD&C YELLOW NO. 5
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.Product 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.
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 thoroughly 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 Flammable. Keep away from fire or flame. For external use only When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts 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