Triclosan
FDA Label NDC 53119-575

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Columbia Jobbing for the product Triclosan (NDC 53119-575). 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 other, active ingredient:, purpose:, uses, warning, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient:

Triclosan (0.35%)

Purpose:

Antiseptic Hand Cleanser

Uses

  • Handwash to help reduce bacteria that potentially can cause disease.
  • Recommended for repeated use.

Warning

  • For external use only
  • Do not use near eyes

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

    • Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor.

    In case of eye contact, flush with water for 15 minutes. If irritation persists, get medical attention. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

  • Wet hands and forearms
  • Apply appropriate amount to hands and forearms
  • Scrub hands and forearms thoroughly for 60 seconds
  • Use scrub and/or nail brush to aid in cleaning.
  • Rinse well
  • Wipe dry with towel, repeat as necessary.

Other Information

  • Assists with OSHA bloodborne pathogen standard compliance

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Cocamide DEA, Cocamidopropyl betaine, Sodium Cumene Sulfonate, Citric Acid, Fragrance, DMDM Hydantoin, Sodium Chloride, FD&C Green #3.

Package Label.Principal Display Panel

Principal Display Panel

Bio CLEAN

Foaming Antiseptic Hand Cleaner

A powerful antiseptic cleanser for handwashing

  • Enhanced with moisturizers
  • Reduces bacteria on skin that can potentially cause disease
  • Assists with OSHA bloodborne pathogen standard compliance

    • KEEP OUT OF REACH OF CHILDREN

    CAUTION

    See Drug Facts for panel for additional information.

    Principal Display Panel (Bio02 0000 01)

    Principal Display Panel (Bio02 0000 01)

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