Winning Hands Premium Antibacterial
FDA Label NDC 65601-736

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Betco Corporation, Ltd. for the product Winning Hands Premium Antibacterial (NDC 65601-736). 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 winning hands premium antibacterial, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Winning Hands Premium Antibacterial

​Active Ingredient

​ ​Chloroxylenol 0.5%

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, Coco Diethanolimide, Cocamidopropyl Betaine, Phenoxyethanol, Sodium Laureth Sulfate, Allantoin, DMDM Hydantoin, Fragrance, Aloe Barbadensis Leaf Juice, Glycerine, FD&C Yellow #5, FD&C Red #40.

        Questions or Comments?Phone: (800) 777-9343

        MDS information:​(800) 891-4965

        Purpose

        Antibacterial

        KEEP OUT OF REACH OF CHILDREN

        Winning Hands Premium Antibacterial

        SKIN CLEANSER

        Premium Antibacterial Skin Cleanser with Chloroxylenol (PCMX), Aloe and Allantoin

        Net Contents: 30.4 fl. oz. (900 mL)

        73619.jpg (73619)

        73619.jpg (73619)

* Please review the disclaimer below.