Haring B Detox Mouthwash
FDA Label NDC 69255-400

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jangin Pharm Co.,ltd. for the product Haring B Detox Mouthwash (NDC 69255-400). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Inactive Ingredient

Preservative : Sodium Benzoate

Additives : Allantoin, Glycerin, Ethyl alcohol, Xylitol, Citric Acid Hydrate, Sodium Citrate Hydrate, Caramel Colorant, Glycyrrhiza Inflata Root Extract, Sophora Angustifolia Root Extract, Swertia Japonica Extract, camellia sinensis catechins, Red Ginseng Extract, Saccharin Sodium Hydrate, Polyoxyl 40 Hydrogenated Castor Oil, L-Menthol, Fragrance(Peach Flavor 7), DI-Water

Otc - Purpose

It keeps your teeth white, strong, and clean your mouth. It makes your mouth feel fresh, prevent cavities, and remove bad breath. Increase the aesthetic effect. Prevent gingivitis, periodontitis (pyorrhoea alveolaris), periodontal disease, and gum disease.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

● Administration and doses : Hold a suitable amount (10~15ml) in your mouth for about 30 seconds, then spit it out, and brush your teeth with a brush.

Warnings

● Caution : 1) The fluoride content of toothpaste is 90.5 ppm. 2) Take care not to swallow, and rinse your mouth thoroughly after use. 3) If gum or mouth damage is caused by using this toothpaste, stop using it and consult a doctor or dentist. 4) If used by children under the age of six years, use small amount of toothpaste about the size of peas at a time. Use under supervision of a guardian to avoid sucking or swallowing. 5) If a child under 6 years old swallows a large amount, consult a physician or dentist immediately. 6) Keep out of the reach of children under 6 years old. 7) This medicine contains sodium benzoate which can cause slight irritation to the skin, eyes and mucous membrane. 8) This product contains fluoride and ethanol and requires guidance from parents or adults when used by children. 9) This product contains ethanol(alcohol), so be careful when testing ethanol(alcohol) immediately after use as this product may affect the results of drinking measurement.

Dosage & Administration

For dental use only

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