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Product NDC Code | 50428-0031 | ||||
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Drug Name | Safety 1st social safety pack |
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Type | Brand | ||||
Dosage Form | KIT | ||||
RxCUI drug identifier | 581660 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Dorel Juvenile Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Ethyl alcohol 62% 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: Wet hands thoroughly with product and allow to dry without wiping.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Pure water, Glycerine, Carbomer, Triethanolamine, Disodium EDTA
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.Use: For hand washing 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.Safety 1st Social Safety Pack ALCOHOL Safety 1st Hand Sanitizer ALCOHOL WATER GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE EDETATE DISODIUM ANHYDROUS 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.50428-001-01 Kit
50428-002-05 Back Front
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
First Aid Measures In case of eye contact: Do not rub eyes, flush eyes with plenty of water for at least 10-15 minutes. If condition worsens or irritation persists, seek medical assistance. If swallowed, seek medical help or contact poison control center right away.
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.
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 Hand sanitizer contains flammable liquid. Keep away from heat/sparks/ open flame & hot surfaces FOR EXTERNAL USE ONLY Keep out of reach of children.
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