Royal Antibacterial (coconut And Lime) Moisturizing Hand Cleanse
FDA Label NDC 50438-603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Royal Antibacterial (coconut And Lime) Moisturizing Hand Cleanse (NDC 50438-603). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Triclosan 0.15%

Purpose

Antibacterial

Uses

for handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When Using This Product

Avoid contact with eyes. In case of eye contact, flush with water.

Stop Use And Ask A Doctor

If irritation and redness develops.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Fragrance, Citric Acid, Peg-150 Distearate, Tetrasodium Edta, FD&C Yellow No.5, FD&C Blue No.1

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