Coralite Antibacterial Moist Solution
FDA Label NDC 65923-831

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Coralite Antibacterial Moist (NDC 65923-831). 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 drug facts, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts


Active Ingredient                                                                                      Purpose

Benzalkonium Chloride 0.115%............................................................ Antibacterial

Otc - Purpose

Uses

  • Decreases bacteria on skin and surfaces

Warnings

Warnings

For external use only

Otc - Stop Use

Stop use and ask a doctor if

  • Irritation or rash develops and persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Directions

  • Peel back seal using tab. Do not pull seal all the way off. Pull sheet from center and remove as needed. Reseal pouch by pressing seal back down to retain moisture after each use.
  • Apply thoroughly to hands and face as desired and allow to dry without wiping.
  • Dispose of wipe in the proper container. Do not flush down the toilet.

Inactive Ingredient

Inactive ingredients

2-Bromo-2-Nitropropane-1,3-Diol,3-Iodo-2-propynyl Butyl Carbamate, Aloe Gel Powder 100:1, Aqua, Chamomilla Recutita Flower Extract (Propylene Glycol, Aqua), Citric Acid, Lauryl Glucoside, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Terasodium EDTA

Dosage & Administration

Distributed by:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703

MADE IN CHINA

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