Otc - Active Ingredient
Sodium fluoride 0.05%
Dentalclean Green Diamond Alcohol Free Mouthwash Rinse
FDA Label NDC 84035-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rabbit Ind�stria E Com�rcio De Produtos De Higiene Pessoal Ltda for the product Dentalclean Green Diamond Alcohol Free Mouthwash (NDC 84035-012). 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, directions, other safety information, inactive ingredients, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity
Indications & Usage
Useaids in the prevention of dental cavities
Warnings
WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.
Directions
Adults and children of 6 years of age and older:
• Use twice a day after brushing your teeth with a toothpaste.
•Remove cap
• Hold bottle upright and squeeze
•Pour out the rinse inside the cap
•Vigorously swish between your teeth for 30 to 60 seconds and then spit out
• Do not swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.
Other Safety Information
Store in a dry, cool place away from sunlight.
Inactive Ingredients
Water, Glycerol, PEG-40 Hydrogenated Castor Oil, Sorbitol, Aroma, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Yellow 5 (CI 19140), Blue 1 (CI 42090), Cinnamaldehyde, Eugenol.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Package Label.Principal Display Panel
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