Label: SALIVEA- fluoride toothpaste paste, dentifrice
- NDC Code(s): 54897-701-13
- Packager: Laclede, 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 February 11, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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.
- To minimize swallowing for children under 6, use a pea-size amount and supervise brushing until good habits are established. Children under 2 years ask a dentist or physician.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SALIVEA
fluoride toothpaste paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54897-701 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) ISOCETETH-20 (UNII: O020065R7Z) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) MINT (UNII: FV98Z8GITP) SODIUM BENZOATE (UNII: OJ245FE5EU) LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49) POTASSIUM THIOCYANATE (UNII: TM7213864A) GLUCOSE OXIDASE (UNII: 0T8392U5N1) LYSOZYME (UNII: 968JKA7T33) LACTOFERRIN, BOVINE (UNII: KG21X1090A) DEXTRANASE PENICILLIUM (UNII: N2161X1O5O) CALCIUM LACTATE (UNII: 2URQ2N32W3) 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:54897-701-13 121.9 g in 1 TUBE; Type 0: Not a Combination Product 02/19/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/19/2018 Labeler - Laclede, Inc. (098835994) Registrant - Laclede, Inc. (098835994) Establishment Name Address ID/FEI Business Operations Laclede, Inc. 098835994 manufacture(54897-701)