CARBAMIDE PEROXIDE

Carbamide peroxide otic solution at 6.5% weight by volume is specified as an over-the-counter product for use in the ears only, intended for adults and children 12 years of age and older. Each unit is a 0.5 fluid ounce bottle, with a total shelf life of 18 months and a minimum of 15 months of remaining shelf life required upon receipt by the first government activity. The product must be stored between 20°C and 25°C (68°F to 77°F) and packaged in accordance with Medical Marking Standard No. 1, which supersedes MIL-STD-129. Packaging must be commercial, sealed, and designed to prevent damage during transport, with exterior shipping containers meeting standards for safe and cost-effective delivery by common carriers. The item is regulated by the FDA and classified as a TYPE I (CODE K) medical supply with a non-extendable shelf-life requirement. The supplier must comply with OSHA’s revised Hazard Communication Standard, submitting Safety Data Sheets and compliant labels in accordance with 29 C.F.R. 1910.1200 prior to award, and must ensure employee training on these requirements. The contract specifies a delivery of three bottles to APO 96543-4010 within 20 days under FOB destination terms with no quantity variance allowed. The National Stock Number is 6505-01-184-1250, and the supplier is The Harvard Drug Group, L.L.C. with multiple part numbers including P/N 370528, P/N 700838, and NDC 00904-7478-35. All technical and quality requirements are governed by the DLA Master List of Technical and Quality Requirements referenced in the solicitation.