Label: QUIP- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69261-004-01, 69261-004-02 - Packager: Quip NYC Inc.
- Category: HUMAN OTC DRUG LABEL
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 April 9, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- adults and children 2yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as instructed by a dentist
- do not swallow
- to minimize swallowing use a pea-sized amount in children under 6
- supervise children's brushing until good habits are established
- children under 2 years: ask a dentist
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUIP
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69261-004 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.23 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) CARRAGEENAN (UNII: 5C69YCD2YJ) HYDROGEN PEROXIDE (UNII: BBX060AN9V) MENTHOL (UNII: L7T10EIP3A) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) Product Characteristics Color white Score Shape Size Flavor WATERMELON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69261-004-01 133 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2019 2 NDC:69261-004-02 24 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/01/2019 Labeler - Quip NYC Inc. (079453380)