2080 K Original
FDA Label NDC 71401-0007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ak America for the product 2080 K Original (NDC 71401-0007). 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 - keep out of reach of children, otc - stop use, indications & usage, dosage & administration, inactive ingredient, 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: Sodium Fluoride 0.22% (0.1% w/v fluoride)

Otc - Purpose

Purpose: anticavity

Warnings

Do not use this product for purposes other than those described on the label.  In case of eye contact, rinse off immediately with water.  If irritation persists, seek medical help.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children under 6 years of age

Otc - Stop Use

Stop using this product and consult your dentist if irritation to gums, teeth, or oral mucosa occurs

Indications & Usage

Do not swallow.  Rinse mouth with water after brushing.

Children under 6 years:

    - To minimize swallowing, use a pea-sized amount.  Supervise brushing until good habits are established.

    - If swallowed more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

This toothpaste contains 1,000 ppm fluoride

Inactive Ingredient

Inactive Ingredients: Liquid Sorbitor, Water, Silicon Dioxide, Polyethylene Glycol 1500, Sodium Lauryl Sulfate Flavor, Sodium Chloride, Sodium Carboxymethylcellulose, Saccharin Sodium Hydrate, Phosphoric Acid, Panthenol, Ginkgo Biloba Leaf Extract, Erythritol, Yellow#203, Blue#1

* Please review the disclaimer below.