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Product NDC Code | 10565-076 | ||||||||||
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Drug Name | Instant hand sanitizer |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | GEL | ||||||||||
RxCUI drug identifier | 581662 | ||||||||||
Application Number | 505G(a)(3) | ||||||||||
Labeler Name | Hydrox Laboratories | ||||||||||
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 place enough product in your palm to thoroughly cover your hands rub hands together briskly until dry children under 6 years of age should be supervised when using this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, purified water, tocopheryl acetate, aloe vera gel, AMP-95
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 that could cause disease
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.Instant Hand Sanitizer Alcohol CARBOMER HOMOPOLYMER TYPE C GLYCERIN ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE PROPYLENE GLYCOL WATER ALPHA-TOCOPHEROL ACETATE ALOE VERA LEAF AMINOMETHYLPROPANOL 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.PRINCIPAL DISPLAY PANEL NDC 10565-076-04 Hydrox Laboratories INSTANT HAND SANITIZER with moisturizers aloe & vitamin E KILLS 99.9% OF GERMS* 4 FL OZ 118 mL Made in USA Principal Display Panel - 59 mL Cylinder Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
MFG BY: HYDROX LABORATORIES 825 Tollgate Road ELGIN, IL 60123
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 accidently ingested, seek medical help or contact a Poison Control Center immediately.
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 physician if skin irritation or rash develops.
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.For external use only - hands. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at normal room temperature may discolor certain 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 Flammable. Keep away from fire or flame For external use only - hands. 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 physician if skin irritation or rash develops. Keep out of reach of children. If accidently ingested, seek medical help or contact a Poison Control Center immediately.
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