Xtracare Antibacterial Hand Cleanse
FDA Label NDC 57337-022

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, Inc. for the product Xtracare Antibacterial Hand Cleanse (NDC 57337-022). 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

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

Otc - Purpose

Antibacterial moisturizing Hand Soap

Original

Kills the Germs

Elimiates bacteria on hands

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

Uses

for hand washing to decrease bacteria on the skin.

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 and dry thoroughly.

Inactive Ingredient

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c yellow no. 5, d&c red no. 33.

Other Safety Information

Other information

  • store at room temperature
    • DISTRIBUTED BY:REJOICE INTERNATIONAL, INC.48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USAMADE IN CHINA

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