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Instant hand sanitizer - Medication Information

Product NDC Code 10565-076
Drug Name

Instant hand sanitizer

Type Brand
Active Ingredients
Alcohol 70 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581662
Application Number 505G(a)(3)
Labeler Name Hydrox Laboratories
Packages
Package NDC Code Description
10565-076-02 59 ml in 1 cylinder (10565-076-02)
10565-076-04 118 ml in 1 cylinder (10565-076-04)
10565-076-08 237 ml in 1 bottle, pump (10565-076-08)
10565-076-16 473 ml in 1 bottle, pump (10565-076-16)
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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