Otc - Active Ingredient
Active ingredient(s)
Cetylpyridinium Chloride 2.296%
Cloveden 100 Times Higher Concentrated Mouthwash
FDA Label NDC 84516-040
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 100 Times Higher Concentrated (NDC 84516-040). 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, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiplaque
Indications & Usage
Use(s)
■ Refreshing the mouth
■ Plaque removal
■ Oral cleanliness
■ Bad breath removal
Warnings
Warnings
■ 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 6 years of age and older:
■ use twice a day after brushing your teeth with a toothpaste
■ vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
■ do not swallow the rinse
■ do not eat or drink for 30 minutes after rinsing
■ instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
■supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor
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
Otc - Questions
Questions
■ https://acuseplanet.cafe24.com/shop2/
■ Customer center : 82-70-8065-7737
Inactive Ingredient
Inactive ingredients
Water, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Sodium Saccharin, Sodium Citrate, Herb-Mint Flavor, Menthol, Mentha Piperita Oil, Xylitol, Sucralose, Citric Acid, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Camellia Sinensis Leaf Extract, Brilliant Blue FCF
* Please review the disclaimer below.
