Otc - Active Ingredient
Active ingredient(s)
Silica 7.0%
Hydrogen Peroxide(35%) 2.14%
Tocopheryl Acetate 0.2%
Cloveden Vegan Whitening Tooth Paste, Dentifrice
FDA Label NDC 84516-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acuseplanet Inc for the product Cloveden Vegan Whitening Tooth (NDC 84516-030). 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, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiplaque
Whitening
Antigingivitis
Indications & Usage
Use(s)
■ Whitens teeth.
■ Prevents cavities and eliminates bad breath.
■ Strengthens teeth.
■ Keeps the oral cavity clean.
■ Refreshes the oral cavity.
■ Enhance the aesthetic effect.
■ Prevention of gingivitis, periodontitis (pyorrhoea).
■ Prevention of periodontal disease.
■ prevention of gum disease.
■ Remove dental plaque (anti-prag)
Warnings
Warnings
■ Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
Directions
■ adults and children 2 years of age and older : brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
■ children 2 to 6 years : use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
■ children under 2 years : ask a dentist or physician
Other Safety Information
Other Information
■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light
Questions
■ https://acuseplanet.cafe24.com/shop2/
■ Customer center : 070-8065-7737
Inactive Ingredient
Inactive ingredients
Water, Glycerin, Sodium Cocoyl Glutamate, Sodium metaphosphate, Xylitol, Xanthan gum, Menthol, Citrus Limon Fruit Oil, Poloxamer 407, Apple-Chamomile Mint Flavor, Double Mint Flavor, Citric Acid, Sucralose, Cooling Flavor, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Disodium EDTA, Hydroxyapatite, Solanum Lycopersicum Fruit Extract, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis Leaf Extract, Citrus Limon (Lemon) Fruit Extract
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