MEIJER WHOLE CARE WITH FLUORIDE- sodium monofluorophosphate paste, dentifrice

Meijer Whole Care with Fluoride by

Drug Labeling and Warnings

Meijer Whole Care with Fluoride by is a Otc medication manufactured, distributed, or labeled by Meijer, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

PURPOSE

Anticavity

INDICATIONS & USAGE

aids in the prevention of dental cavities

WARNINGS

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, sodium lauroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

Principal Display Panel

INGREDIENTS AND APPEARANCE

MEIJER WHOLE CARE WITH FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-0020
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
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ZINC CITRATE (UNII: K72I3DEX9B)
CARRAGEENAN (UNII: 5C69YCD2YJ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Product Characteristics
Color	white (Off White)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-0020-9	1 in 1 CARTON	12/29/2020	09/01/2025
1		155.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/29/2020	09/01/2025

Labeler - Meijer (006959555)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(79481-0020) , pack(79481-0020)