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| Product NDC Code | 76138-116 | ||||
|---|---|---|---|---|---|
| Drug Name | 5406 hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 581660 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Innovation Specialties | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient: Ethyl alcohol 62%.
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.Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.
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.For handwashing to decrease bacteria on the skin.
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.5406 hand sanitizer Ethyl alcohol CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER 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.Packaging image description
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
Made in China For Innovation Line Los Angeles, CA 90066 Product # 5406
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? HOTLINE # 1-855-755 5346 NPN# 80062390
Storage and handling
Information about safe storage and handling of the drug product.Store at room temperature 15° to 30°C (59° to 86°F).
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. Do not use in the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.
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