NATURAL ADULT FLUORIDE- sodium monofluorophosphate paste

Natural Adult Fluoride by

Drug Labeling and Warnings

Natural Adult Fluoride by is a Otc medication manufactured, distributed, or labeled by Kroger, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Sodium monofluorophosphate 0/76% (0.13% w/v fluoride ion) . . . Anticavity

PURPOSE

Uses

aids in the prevention of dental cavities

WARNINGS

Keep out of reach of children under 6 years of age. If more than is swallowed for brushing si accidentally swallowed, 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATURAL ADULT FLUORIDE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-223
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)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
BENZYL ALCOHOL (UNII: LKG8494WBH)

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: 30142-223-39	1 in 1 CARTON	06/02/2020
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	06/02/2020

Labeler - Kroger (006999528)

Registrant - Lornamead Products (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Products		119559733	manufacture(30142-223) , pack(30142-223)