Label: CHARM-TEX FLUORIDE GEL- sodium fluoride paste, dentifrice
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NDC Code(s):
77573-012-01,
77573-012-02,
77573-012-03,
77573-012-04, view more77573-012-05, 77573-012-06, 77573-012-07
- Packager: Jiangsu Aimeili Cosmetic Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Uses
- Warnings
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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 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing
- Children under 2 years: Ask a dentist or physician
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHARM-TEX FLUORIDE GEL
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77573-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77573-012-01 1000 in 1 PACKAGE 07/11/2022 1 7.1 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:77573-012-02 720 in 1 PACKAGE 07/11/2022 2 17 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:77573-012-03 720 in 1 PACKAGE 07/11/2022 3 24 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:77573-012-04 144 in 1 PACKAGE 07/11/2022 4 43 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:77573-012-05 144 in 1 PACKAGE 07/11/2022 5 78 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:77573-012-06 60 in 1 PACKAGE 07/11/2022 6 130 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:77573-012-07 60 in 1 PACKAGE 07/11/2022 7 181 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 Drug M021 07/10/2022 Labeler - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077) Registrant - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077) Establishment Name Address ID/FEI Business Operations Jiangsu Aimeili Cosmetic Co.,Ltd. 543903077 manufacture(77573-012)