KROGER COMPANY RADIANT WHITE- fluoride paste, dentifrice

Kroger Company by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)..................................Purpose: Anticavity

Uses

aids in the prevention of dental caviites

WARNINGS

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

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

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

glycerin, dicalcium phosphate, PEG-12, PVP, PEG/PPG 116/66 copolymer, hydrated silica, hydrogen peroxide, propylene glycol, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

DOSAGE & ADMINISTRATION

Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

KROGER COMPANY  RADIANT WHITE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-621
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
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
PHOSPHORIC ACID (UNII: E4GA8884NN)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-621-69	1 in 1 CARTON	05/29/2014
1	NDC: 30142-621-62	155 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 final	part355	02/24/2014

Labeler - Kroger Company (006999528)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(30142-621) , pack(30142-621)