Royal Antibacterial Tropical Fruit Hand Cleanse
FDA Label NDC 50438-108

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 Tropical Fruit Hand Cleanse (NDC 50438-108). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

Otc - Purpose

Uses

for handwashing to decrease bacteria on the skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Wet hand, apply to hands, scrub thoroughly, Rinse.

Warnings

Warnings

For external use only.

Avoid getting into eyes. If this happens, rinse thoroughly with water.

Dosage & Administration

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Inactive Ingredient

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

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