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| Product NDC Code | 71884-015 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pharma-care skin preparation cloths |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CLOTH | ||||||
| RxCUI drug identifier | 1038558 | ||||||
| Application Number | part333E | ||||||
| Labeler Name | Enviro Specialty Chemicals Inc | ||||||
| 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: DO NOT MICROWAVE Product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products. Using sterile scissors, cut off end seal of satchel. Transfer contents onto prep table.To reduce the risk of cloth contamination, avoid contact between cloths and the outside of package. Use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use the second cloth to prepare larger areas. For dry surgical sites such as abdomen or arm, use one cloth to cleanse each 5 in. x 5 in. area (approx. 161 sq. cm) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting the treatment area. Discard cloth. Allow area to air dry for one (1) minute. Do not rinse. For moist surgical sites such as inguinal fold, use one cloth to cleanse 2 in. x 5 in. (approx. 65 sq. cm) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting the treatment area. Discard cloth. Allow area to air dry for one (1) minute. Do not rinse. Discard each cloth after single use. After satchel has been opened, discard any unused cloths.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium 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 preparation of skin pre and post surgery Helps reduce bacteria on the skin.
Purpose
Information about the drug product’s indications for use.PURPOSE: Antiseptic Skin Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Pharma-Care Skin Preparation Cloths Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM ALOE VERA LEAF WATER CITRIC ACID MONOHYDRATE CAPRYLYL GLUCOSIDE LAURETH-4 POLIHEXANIDE PHENOXYETHANOL TRIETHOXYSILYLPROPYL STEARDIMONIUM 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 Phcare1
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
RINSE FREE LONG LASTING, ALCOHOL-FREE PROTECTION FROM MICROORGANISMS Formulated and enhanced with Zetrisil A PROPRIETARY SILICONE QUATERNARY SOLUTION + Fast-acting, 15-second formula + Last up to 4 hours + No natural rubber or latex + Non-sterile DO NOT MICROWAVE Please dispose of used wipes responsibly. Do not dispose used wipes down the toilet. Not made with natural rubber latex. ESC BRANDS DISTRIBUTED BY: ESC BRANDS, LLC. OLD HARGRAVE ROAD, SUITE B LEXINGTON, NC 27295 888-331-8332 www.escbrands.com FORMULATED IN THE USA MADE IN CHINA
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.CAUTION: KEEP OUT OF REACH OF CHILDREN
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? Call +1(888) 331-8332 Mon-Fri 9.00 AM - 5.00 PM (EST)
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION: Store product flat and between 68-77° F (20 - 25° C) Avoid excessive heat above 104° F (40° C)
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: • Single use only • Do not freeze • For external use only • Do not use in ears, eyes or mouth • Use with care in premature infants or infants under 2 months of age • Avoid contact with the eyes. In case of contact, flush eyes with water • Stop use and ask a doctor if skin redness or irritation develops • If swallowed, get medical help immediately CAUTION: 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