Active Ingredient:
Sodium fluoride - 0.243% (0.15% w/v Fluoride ion)
Sodium Fluoride Paste, Dentifrice
FDA Label NDC 67239-0226
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safco Dental Supply Llc for the product Sodium Fluoride (NDC 67239-0226). 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 active ingredient:, purpose:, use:, otc - keep out of reach of children, directions:, other ingredients:, principal display panel – 24 g box label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Anti-cavity
Use:
Helps protect against cavities
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.
Directions:
Adults and Children 6-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 a 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 a physician
Other Ingredients:
Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose gum and/or Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Tetra Sodium Pyrophosphate, Glycerin, Color: FD&C Blue #1
Package date and batch number on crimp.
Principal Display Panel – 24 G Box Label
Quantum
Fresh
FLUORIDE TOOTHPASTE
Quantum
a safco company
800-328-8213
www.QuantumLabs.com
Fluoride Toothpaste
Reorder # 826-0001
Net Wt. 0.85 oz (24 g)
Expiration Date:
2 years from date
packed.
NDC 67239-0226-0
Made in India
Principal Display Panel – 24 G Box Label (Qua03 0000 01)
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