Label: QUIP ANTICAVITY- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69261-006-01, 69261-006-06, 69261-006-07, 69261-006-08 - Packager: Quip NYC Inc.
- 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 May 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 2 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 doctor.
- Use only a pea-sized amount and instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision
- Children under 2 years of age: consult a dentist or doctor.
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- Carton
- Tube
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INGREDIENTS AND APPEARANCE
QUIP ANTICAVITY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69261-006 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 SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) XYLITOL (UNII: VCQ006KQ1E) ERYTHRITOL (UNII: RA96B954X6) CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 2300 MPA.S AT 1%) (UNII: 0Z2R7OG99L) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69261-006-01 1 in 1 CARTON 01/25/2021 1 133 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69261-006-06 133 g in 1 TUBE; Type 0: Not a Combination Product 01/25/2021 3 NDC:69261-006-08 1 in 1 CARTON 07/15/2021 3 130 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:69261-006-07 130 g in 1 TUBE; Type 0: Not a Combination Product 07/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/25/2021 Labeler - Quip NYC Inc. (079453380)