Active Ingredient
Sodium Fluoride 0.76%(0.1%w/v fluoride ion)
Charm Tex Fluoride
FDA Label NDC 51289-200
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 Hengyuan Daily Chemical Plastic Co., Ltd. for the product Charm Tex Fluoride (NDC 51289-200). 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, warning, directions, inactive ingredients, keep out of reach of children under 6 years of age, 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
Purpose
Anticavity
Use
helps protect against cavities
Warning
Keep out of 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.
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:Use only a pea sized amount and supervise child’s brushing and rinsing to minimize swallowing.
Children under 2:Ask dentist or physician
Inactive Ingredients
Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavour, Treated Water, SCMC,
Sodium Lauryl Sulfate
Keep Out Of Reach Of Children Under 6 Years Of Age
Keep out of reach of children under 6 years of age
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
