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DRUG FACTS
Exclusive Distributor: Charm-Tex, Inc. USA
Charm Tex
FDA Label NDC 40057-1001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Charm Tex, Inc. for the product Charm Tex (NDC 40057-1001). 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 other, active ingredient, purpose, use, otc - keep out of reach of children, otc - when using, inactive ingredient, adults and children 6 years of age and older, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.22% (0.1% w/v fluoride ion)
Purpose
Anticavity
Use
helps protect against cavities.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children under 6 years of age.
Otc - When Using
If more than used for brushing is accidently swallowed, get medical help or contact a poison control centre immediately.
Inactive Ingredient
Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin,Treated water, SCMC, Sodium Lauryl Sulfate.
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 physician.
Principal Display Panel - 42.5 Grams Tube Label
Charm-Tex
FLUORIDE GEL TOOTHPASTE
Net Wt. 1.5 oz.
42.5 Grams
Principal Display Panel (42.5 Grams Tube Label)
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