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Color element advanced hand sanitizer - Medication Information

Product NDC Code 74934-003
Drug Name

Color element advanced hand sanitizer

Type Brand
Active Ingredients
Alcohol .75 ml/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1305100
Application Number 505G(a)(3)
Labeler Name Zhejiang iColor Biotech Co., Ltd
Packages
Package NDC Code Description
74934-003-38 3800 ml in 1 bottle (74934-003-38)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Ethyl Alcohol 75% v/v Purpose Antiseptic

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 on hands to cover all surfaces. Rub hands together until dry. Children under 6 years of age should be supervised by adult when applying this product. Do not use on children less than 2 months of age or on open skin wounds.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Glycerin, Squalane, Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, AMinomethyl Propanol.

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 For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available.

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.
Color Element Advanced Hand Sanitizer ALCOHOL WATER GLYCERIN SQUALANE PANTHENOL INULIN HYALURONATE SODIUM FRUCTOSE .ALPHA.-TOCOPHEROL ACETATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 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.
Package Labeling: Bottle

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.
Other information Store between 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F) May discolor some fabrics or surfaces

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 on the skin.

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 eyes,ears and mouth. In case of contact with eyes, 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 For external use only Flammable. Keep away from heat or flame When using this product do not use in or near eyes,ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears on the skin. 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