Active Ingredient
sodium fluoride 0.24%（0.14% w/v fluoride ion）
Plak Smacker Anti-cavity Fluoride Gel
FDA Label NDC 71167-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Huaian Zongheng Bio-tech Co., Ltd for the product Plak Smacker Anti-cavity Fluoride Gel (NDC 71167-005). 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
Anticavitytoothpaste
Use
helps aid in the prevention of dental 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 right away.
Directions
Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children as necessary until capable of using without supervision
Inactive Ingredients
sorbitl,water,silicon dioxide,glycerin,saccharin sodium,PEG-8,sodium carboxymethyl cellulose ,lauryl sodium sulfate,aroma,sodium benzoate,ci42090anium Dioxide),Sodium saccharin,rose canina fruit oil
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
2 (0051)
1 (005)
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