Supreme
FDA Label NDC 68304-141

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Brookmeade Hardware & Supply Co. for the product Supreme (NDC 68304-141). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding supreme, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Supreme

​Active Ingredient

Chloroxylenol 0.375%

Uses

  • ​​Antibacterial hand cleaner.
  • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

    • Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.

      • Directions

      • ​Read the entire label before using this product.
      • ​Dispense 1-2 pumps of product onto wet palm.
      • Lather and rinse hands with clean water

        • Inactive Ingredients

        ​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

        Purpose

        Antibacterial

        KEEP OUT OF REACH OF CHILDREN

        Supreme

        Antiseptic Hand Cleaner

        Pearlized Antibacterial Skin Cleanser with PCMX

        BROOKMEADE HARDWARE & SUPPLY CO., Nashville, Tenn. 37210

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