Natoral Korean Ginseng
FDA Label NDC 71211-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natoral Limited for the product Natoral Korean Ginseng (NDC 71211-001). 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, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Menthol 0.03%

Otc - Purpose

Antigingivitis

Indications & Usage

Helps control plaque that leads to gingivitis.

Dosage & Administration

Adults and children 12 years of age and older Vigorously swish 20mL (2/3 FL OZ or 4 teaspoonful) between teeth for 30 seconds then spit out; do not swallow
Children under 12 years of age Consult a dentist or doctor
Children under 6 years Do not use unless directed by a dentist or a physician

  • This rinse is not intended to replace brushing or flossing.

Warnings

  • Do not use if you have painful or swollen gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease. Do not give to children under 12 years of age.
    • Stop Use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks.

Otc - Keep Out Of Reach Of Children

Do not give to children under 12 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Water, Glycerin, PEG-60 Hydrogenated Castor Oil, Propolis Extract, Citric Acid, Sodium Benzoate, Camellia Sinensis Leaf Extract, Xylitol, Panax Ginseng Root Extract, Flavor, Sodium Citrate, Caramel, Malic Acid, Sodium Saccharin

Package Label.Principal Display Panel

12 mL Sachet x 6

260 mL Bottle

520 mL Bottle

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