Label: PHARMA-CARE SKIN PREPARATION CLOTHS- benzalkonium chloride cloth
- NDC Code(s): 71884-015-02, 71884-015-24
- Packager: Enviro Specialty Chemicals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 14, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- QUESTIONS?
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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.
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SPL UNCLASSIFIED SECTION
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
- Packaging
-
INGREDIENTS AND APPEARANCE
PHARMA-CARE SKIN PREPARATION CLOTHS
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71884-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) LAURETH-4 (UNII: 6HQ855798J) POLIHEXANIDE (UNII: 322U039GMF) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71884-015-02 2 in 1 PACKET 08/14/2020 1 26.5 mL in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:71884-015-24 24 in 1 CASE 08/14/2020 2 2 in 1 PACKET 2 26.5 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/14/2020 Labeler - Enviro Specialty Chemicals Inc (202621850)
