Label: CHARM TEX FLUORIDE- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 71035-200-01, 71035-200-02, 71035-200-03, 71035-200-04, view more71035-200-05, 71035-200-06, 71035-200-07, 71035-200-08, 71035-200-09, 71035-200-10, 71035-200-11, 71035-200-12, 71035-200-13, 71035-200-14, 71035-200-15, 71035-200-16 - Packager: Yangzhou Hongshengding Chemical Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warning
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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
- Keep out of reach of children under 6 years of age
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHARM TEX FLUORIDE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71035-200 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) CALCIUM CARBONATE (UNII: H0G9379FGK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71035-200-01 17 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 2 NDC:71035-200-02 24 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 3 NDC:71035-200-03 35 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 4 NDC:71035-200-04 43 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 5 NDC:71035-200-05 50 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 6 NDC:71035-200-06 70 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 7 NDC:71035-200-07 78 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 8 NDC:71035-200-08 90 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 9 NDC:71035-200-09 100 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 10 NDC:71035-200-10 120 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 11 NDC:71035-200-11 130 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 12 NDC:71035-200-12 150 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 13 NDC:71035-200-13 180 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 14 NDC:71035-200-14 3 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 15 NDC:71035-200-15 5 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 16 NDC:71035-200-16 10 g in 1 TUBE; Type 0: Not a Combination Product 10/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/20/2016 Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755) Establishment Name Address ID/FEI Business Operations Yangzhou Hongshengding Chemical Co.,Ltd. 543774755 manufacture(71035-200)
