Coralite Ultra Antibacterial Deodorant
FDA Label NDC 65923-807

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 Ultra Antibacterial Deodorant (NDC 65923-807). 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, 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.

Otc - Active Ingredient

Active ingredient                                                            Purpose

Triclocarban 0.3%....................................................Antibacterial

Otc - Purpose

Uses

  • for washing to decrease bacteria on the skin

Warnings

Warnings For external use only.

Otc - When Using

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develops.

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

Directions

  • wet bar with water
  • lather vigorously and wash skin
  • rinse and dry thoroughly

Inactive Ingredient

Inactive ingredients soap (sodium tallowate, sodium cocoate, sodium palmate types), water, glycerin, fragrance, sodium chlroide, palm acid or tallowate acid, PEG-6 methyl ether, sorbitol, tetrasdoium etidronate, BHT, pentasodium pentetate, FD&C yellow no. 5, D&C yellow no. 8, FD&C red no. 4

Dosage & Administration

Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Description (Pa 56107.01 Co Ultraantibactsoap Ct)

Image Description (Pa 56107.01 Co Ultraantibactsoap Ct)

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