Otc - Active Ingredient
Sodium monofluorophosphate 0.76% (0.76g/100g)
Carekon Anti-cavity Fluoride Paste
FDA Label NDC 84345-086
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hunan Yinhuatang Pharmaceutical Technology Co., Ltd. for the product Carekon Anti-cavity Fluoride (NDC 84345-086). 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, dosage & administration, inactive ingredient, 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
Anticavity
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age
Indications & Usage
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 doctor.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
Warnings
Keep out of 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.
Dosage & Administration
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 doctor.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
Inactive Ingredient
Sorbitol, Water, Hydrated Silica, Dicalcium Phosphate, Hydroxyapatite, Glycerin, Cocamidopropyl Betaine, Sodium Lauroyl Sarcosinate, Fragrance, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Saccharin, Citric Acid, Beta-Glucan
Package Label.Principal Display Panel
Yht1 (Yht1)
Yht2 (Yht2)
* Please review the disclaimer below.
