CARBAMIDE PEROXIDE

CARBAMIDE PEROXIDE
CARBAMIDE PEROXIDE OTIC SOLUTION
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RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS
(IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE
DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB
AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
OVER-THE-COUNTER (OTC); FOR USE IN THE EYES ONLY.
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FOR ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER.
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ROUTE : ,,,,OTIC
DOSE FORM : ,,DROPS
STRENGTH : ,,,,6.5 %
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EACH BOTTLE CONTAINS 6.5% WEIGHT BY VOLUME (W/V) OF CARBAMIDE PEROXIDE
AS THE ACTIVE INGREDIENT.
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UNIT OF ISSUE IS A BOTTLE CONTAINING 0.5 FLUID OUNCES.
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TOTAL SHELF LIFE IS 18 MONTHS.
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THERE SHALL BE A MINIMUM OF 15 MONTHS OF REMAINING SHELF LIFE
AT THE TIME OF RECEIPT BY THE FIRST GOVERNMENT ACTIVITY.
.
STORE AT 20° TO 25°C (68° TO 77°F)
.
MARK IN ACCORDANCE WITH MMS No. 1B 30 March 2017 . 5/15/2017 . This device or drug is regulated by the FDA. Note to Buyers: The contracting official shall send a referral in EBS to the product specialist for confirmation. Please include bidder name and bidder contact information, manufacturer name, manufacturer part number, and item description.
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS SPECIFIED IN THE PROCUREMENT DOCUMENT.
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED IN A SUITABLE SEALED UNIT CONTAINER CAPABLE OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
SPE2DP-26-T-3472
SECTION B
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
Hazard Communication Standard Notice:
Effective June 1, 2015, Federal Standard No. 313-E, Material Safety Data, Transportation Data and Disposal Data for Hazardous Materials Furnished to Government Activities, establishes the requirement for preparation and submission of Safety Data Sheets (SDS) in lieu of Material Safety Data Sheets (MSDS) by suppliers who provide hazardous materials to government activities.
The Occupational Safety and Health Administration (OSHA) has modified its Hazard Communication Standard (HCS) to conform to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals. As a result of this change, GSA revised Federal Standard No. 313-E requiring Safety Data Sheets for classifying chemicals and communicating the applicable information on labels.
In accordance with the revised standard after June 1, 2015:
1. Suppliers will be required to submit, to the contracting officer for review and approval prior to award, safety data sheets consistent with the requirements found at 29 C.F.R. 1910.1200 for hazardous materials delivered to the Government.
2. Suppliers will also be required to submit, to the contracting officer for review and approval prior to award, Hazardous Communication Standard (HCS) labels in accordance with 29 C.F.R. 1910.1200 requirements or current Consumer Product Safety Act (CPSA), Federal Hazardous Substance Act (FHSA) labels when subject to labeling requirements under those statutes. This product labeling is required for hazardous materials delivered to the Government.
3. Finally, suppliers must train their employees on the new safety data sheets, hazardous communication labels, and requirements of 29 C.F.R. 1910.1200.
For more information on SDS, refer to OSHAs website, available at:
https://www.osha.gov/law-regs.html
For information on 29 C.F.R. 1910.1200, refer to the below link:
https://www.osha.gov/dsg/hazcom/index.html RS013: Shelf-life requirement RS001 for a TYPE I (CODE K) item with a shelf life of 18 months (non-extendable) applies to this item.
THE HARVARD DRUG GROUP, L.L.C. 1LEZ0 P/N 370528 THE HARVARD DRUG GROUP, L.L.C. 1LEZ0 P/N 700838 THE HARVARD DRUG GROUP, L.L.C. 1LEZ0 P/N NDC00904-7478-35
SPE2DP-26-T-3472
SECTION B
DLA issues this document using the DoD authorized unit of issue, please refer to the following URL to determine the corresponding ANSI X12 unit of issue.
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments% 2FDLMS%2FeApplications%2FLogDataAdmin%2FUnitofIssueandPurchaseUnit.xlsx&wdOrigin=BROWSELINK
CLIN PR PRLI UI QUANTITY UNIT PRICE TOTAL PRICE.
0001 7016815578 0001 BT 19.000
NSN/MATERIAL:6505011841250
DELIVERY (IN DAYS):0020
DELIVER FOB: DESTINATION
QTY VARIANCE: PLUS 0% MINUS 0%
INSPECTION POINT: DESTINATION
ACCEPTANCE POINT: DESTINATION
PREP FOR DELIVERY:
PKGING DATA MIL-STD-2073-1E
SPECIAL NSN/Part Number: 6505-01-184-1250 Quantity: 19 BT Purchase Request: 7016815578QTY: 19 Delivery: 20 days ADO