SALIVEA- fluoride toothpaste paste, dentifrice 
Laclede, Inc.

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.

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Salevia

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

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

image of carton

SALIVEA 
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54897-701
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54897-701-13121.9 g in 1 TUBE; Type 0: Not a Combination Product02/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/19/2018
Labeler - Laclede, Inc. (098835994)
Registrant - Laclede, Inc. (098835994)
Establishment
NameAddressID/FEIBusiness Operations
Laclede, Inc.098835994manufacture(54897-701)

Revised: 2/2023
Document Id: 90d3065d-9432-4fde-83a8-b434526b1801
Set id: 6398ae96-dd38-44da-bc34-1d4d4c4a78ca
Version: 2
Effective Time: 20230211
 
Laclede, Inc.