Otc - Active Ingredient
Active Ingredient
SODIUM MONOFLUOROPHOSPHATE: 0.76% (0.1% Fluoride ion)
Charm Tex Fluoride Paste, Dentifrice
FDA Label NDC 71035-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yangzhou Hongshengding Chemical Co.,ltd. for the product Charm Tex Fluoride (NDC 71035-001). 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, uses, warnings, otc - keep out of reach of children, directions, 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
Purpose: Anticavity
Uses
Help protect against cavities.
Warnings
Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 children's brushing and rinsing to minimize swallowing
- Children under 2 years: Ask a dentist or physician
Inactive Ingredient
Sorbitol, Silica, Calcium Carbonate, Methylparaben Sodium, Propylparaben Sodium, Flavor, Sodium Saccharin, Water, SCMC, Sodium Lauryl Sulfate
* Please review the disclaimer below.
