Soom Mouthwash
FDA Label NDC 79717-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tecozyme Inc for the product Soom Mouthwash (NDC 79717-0001). 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, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, 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

Otc - Purpose

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Adults and children 6 years of age and older

■ Vigorously swish 11 mL between teeth twice a day for 30 seconds then spit out.

■ Do not swallow

■ Children under 6 years of age: do not use

Warnings

Do not use in Children under 6 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, Erythritol, Xylitol, Sodium Benzoate, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Caster Oil, L-Menthol, Zinc Gluconate, Sodium Citrate, Fragrance

Dosage & Administration

For dental use only

Package Label.Principal Display Panel

Label (Label)

Label (Label)

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