KIDS SILLY STRAWBERRY TP- sodium monofluorophosphate paste, dentifrice

Kids Silly Strawberry TP by

Drug Labeling and Warnings

Kids Silly Strawberry TP by is a Otc medication manufactured, distributed, or labeled by HEB, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium monofluorophosphate 0.76% (0.13% fluoride ion)

PURPOSE

Anticavity

INDICATIONS & USAGE

Helps protect against 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 a day, or as directed by a dentist or doctor

* do not swallow

* to minimize swallowing use a pea-sized amoutn in children under 6

* supervise children's brushing until good habits are established

Children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT

glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS SILLY STRAWBERRY TP 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-411
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CARRAGEENAN (UNII: 5C69YCD2YJ)
GLYCERIN (UNII: PDC6A3C0OX)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-411-19	119 g in 1 TUBE; Type 0: Not a Combination Product	07/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/24/2020

Labeler - HEB (007924756)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(37808-411)