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| Product NDC Code | 78674-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Biopure shield |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1020365 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Biopure Services Llc | ||||
| 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%.
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: Foam onto palm, massage into hands and under fingernails, and air dry. Young children use with supervision.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Purified Water, Propylene Glycol, Methyl Anthranilate, Trihydroxysilylpropyldimethylocatedecyl Ammonium Chloride.
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 on the skin that could cause disease.
Purpose
Information about the drug product’s indications for use.Purpose: Antiseptic/Antimicrobial.
Spl product data elements
Usually a list of ingredients in a drug product.bioPURE Shield Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER PROPYLENE GLYCOL METHYL ANTHRANILATE OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE
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
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.ANTIBACTERIAL FOAM PROTECTS SIGNIFICANTLY LONGER THAN ALCOHOL HOURS OF PROTECTION WASH - DRY - APPLY FDA REGISTERED NO ALCOHOL WATER-BASED SAFE FOR KIDS EFFECTIVE AGAINST 99.9% - 99.99% OF COMMON BACTERIA AND MANY DISEASE-CAUSING GERMS This bottle is recyclable. Do your part. bioPURE SHIELD™ (BPS-MAX HS) antimicrobial foam kills germs on contact, plus its unique antiseptic formula continues to kill and protect significantly longer than alcohol without causing skin irritation. 30-day supply when used as directed. [email protected] | www.biopureservice.com Distributed by bioPURE Services LLC, 6221 Riverside Drive, #1N, Dublin, OH 43017 MADE IN THE USA
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 In case of accidental ingestion, get medical help or contact the Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Store: At room temperature not below 33°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.CAUTION: FOR EXTERNAL USE ONLY Avoid contact with eyes. In case of contact, flush with water. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, contact a physician. KEEP OUT OF REACH OF CHILDREN In case of accidental ingestion, get medical help or contact the 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