Xtracare Foam Antibacterial Hand Wash Soap
FDA Label NDC 57337-049

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Foam Antibacterial Hand Wash (NDC 57337-049). 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, other safety information, 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

Benzalkonium Chloride 0.1% ............... Antibacterial

Otc - Purpose

Uses

for hand washing 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

XtraCare® Foam Antibacterial Hand Wash

Kills 99.9% of bacteria

Compare to Lysol® foam antibacterial hand wash

pink cherry blossom

7.5 Fl Oz (221 mL)

Warnings

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.

Dosage & Administration

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse hands with water

Inactive Ingredient

Inactive Ingredients

water, glycerin, lauramine oxide, PEG-150 distearate, cetrimonium chloride, propylene glycol, fragrance, citric acid, tetrasodium EDTA, cocamide MEA, methylchloroisothiazolinone, methylisothiazolinone, D&C red no. 33, FD&C yellow no.5

Other Safety Information

Other Information: store at room temperature.

Questions/Comments? 1-855-345-5575

*This product is not manufactured or distributed by Reckitt Benckiser LLC, the distributor of Lysol® foam antibacterial hand wash.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

* Please review the disclaimer below.