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| Product NDC Code | 74934-048 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Color element alcohol free hand sanitizer |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1049254 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Zhejiang iColor Biotech Co., Ltd | ||||||
| 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 Benzalkonium Chloride 0.13% 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, Propylene Glycol, Polyquaternium-37,Didecyldimonium Chloride,Polyaminopropyl Biguanide, Aloe Barbadensis Leaf Water, Fragrance, Phenoxyethanol.
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 Alcohol Free Hand Sanitizer BENZALKONIUM CHLORIDE WATER PROPYLENE GLYCOL DIDECYLDIMONIUM CHLORIDE POLYAMINOPROPYL BIGUANIDE ALOE VERA LEAF PHENOXYETHANOL BENZALKONIUM CHLORIDE BENZALKONIUM
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:30ml Box4
Package Labeling:2ml 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.Drug Facts
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 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