Germicida
FDA Label NDC 66449-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Roldan, S.a. for the product Germicida (NDC 66449-004). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, 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
Triclosan 2%

Otc - Purpose

Purpose
Antiseptic

Indications & Usage

Use To decrease bacteria on the skin. Recommended for repeated use.

Warnings

Warnings For external use only. Do not use • on broken skin • otherwise than as directed.

Otc - When Using

When using this product • avoid with eyes or on mucous membranes

Otc - Stop Use

Stop use and ask a doctor if  • condition worsens • irritation or redness develops • if condition persists for more than 3 days

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed contact a doctor or Poison Control Center immediately.

Dosage & Administration

Directions Wet skin. Rub bar vigorously over the skin for approximately 2 minutes. Rinse and repeat.

Inactive Ingredient

Inactive ingredients Coconut Oil, FDC Blue 1, Phenol, Tallow and titanium dioxide

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Package Label

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