SALIVEA- fluoride toothpaste paste, dentifrice

Salivea by

Drug Labeling and Warnings

Salivea by is a Otc medication manufactured, distributed, or labeled by Laclede, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

PURPOSE

Anticavity

USES

Aids in the prevention of dental cavities.

WARNINGS

Keep out of the reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age.

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

Store at Room Temperature.

INACTIVE INGREDIENTS

Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, Glucose Oxidase, Lysozyme, Lactoferrin, Dextranase, Calcium Lactate.

QUESTIONS

Questions? Comments? Call toll-free: 1-877-522-5333

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SALIVEA DRY MOUTH CARE TOOTHPASTE

Soothing Mint

with Xylitol & Calcium

INGREDIENTS AND APPEARANCE

SALIVEA 
fluoride toothpaste paste, dentifrice

Product 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)