Label: KIDS STRAWBERRY FTP- sodium monofluorophosphate paste, dentifrice
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- NDC Code(s): 21130-417-79
- Packager: Albertsons
- 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 12, 2023
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- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Warning
If more than used for brushing is accidentally swalloed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor. • 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
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INGREDIENTS AND APPEARANCE
KIDS STRAWBERRY FTP
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-417 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 CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) Product Characteristics Color white Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-417-79 119 g in 1 TUBE; Type 0: Not a Combination Product 10/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/31/2019 Labeler - Albertsons (009137209) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(21130-417) , pack(21130-417)
