Label: PLAK SMACKER ANTI CAVITY FLUORIDE- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 71035-600-01, 71035-600-02 - Packager: Yangzhou Hongshengding Chemical Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 6, 2018
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- Official Label (Printer Friendly)
- Active ingredients
- Uses
- Warnings
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Directions
Adults and children 2years 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 doctor.
Do not swallow
to minimize swallowing use a peasized amount in children under 6
instruct children under 6 years oa age in good brushing and rinsing habits.
supervise children as necessary until capable of useing without supervision
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLAK SMACKER ANTI CAVITY FLUORIDE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71035-600 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) DISODIUM ETHYLENE DIMYRISTAMIDE PEG-15 DISULFATE (UNII: X2CDV8U82V) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71035-600-01 4 in 1 CARTON 02/11/2016 1 144 in 1 BOX 1 24 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71035-600-02 6 in 1 CARTON 02/11/2016 2 12 in 1 BOX 2 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/11/2016 Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755) Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755) Establishment Name Address ID/FEI Business Operations Yangzhou Hongshengding Chemical Co.,Ltd. 543774755 manufacture(71035-600)
