Inactive Ingredient
Other Ingredients - Purified water, glycerin, Xylitol and other sweeteners, Contains F D and C Blue No. 1
Acclean
FDA Label NDC 0404-8016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein Inc. for the product Acclean (NDC 0404-8016). 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 inactive ingredient, otc - active ingredient, indications & usage, dosage & administration, warnings, precautions, 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 - Active Ingredient
Active Ingredient: Sodium Fluoride 1.1%
(0.5% Fluoride Ion)
Indications & Usage
Indications: Helps prevent dental caries and hypersensitivity
Dosage & Administration
Directions: Adults and children six years of age and older should brush with
Acclean Home Care Gel once at bedtime. Apply thin bead of gel to toothbrush
and brush for at least one minute, making sure all tooth surfaces are covered.
Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes
after use. Children six years of age and older: expectorate and rinse thoroughly.
If recommended by your dentist professional, this product can be used in place
of your regular toothpaste.
Warnings
WARNINGS: DO NOT SWALLOW. To avoid ingestion,
supervision is required while children are using this product.
Swallowing excessive amounts of fluoride could cause dental fluorosis.
KEEP OUT OF REACH OF INFANTS AND CHILDREN.
Precautions
Enter section text here PRECAUTIONS: Federal (USA) Law
prohibits dispensing without prescription. Store at controlled
room temperature 68 - 77 F (20 - 25 C).
Package Label.Principal Display Panel
Copy Of Label (Schein Label)
* Please review the disclaimer below.
