Active ingredients

SODIUM FLUORIDE 0.24% (0.10 w/v Fluoride ion)

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Purpose

Anti-cavity toothpaste

Uses

Aids in the prevention of cavities.

Warnings

Keep out of the reach of children under 6 years of age. If you accidently swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

Do not use if the inner foil is torn, cut, or missing

Keep out of reach of children.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician
Do not swallow
To minimize wallowing, use a pea sizes amount in children under 6 years
Supervise children's brushing until good habits are established
Children under 2 years of age: consult a dentist or physician

INACTIVE INGREDIENT

Sorbitol, Water, Silica, PEG-400, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium sacharine, Sodium benzoate, Trisodium phosphate, CI 42090

Label

PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70766-012
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
TRISODIUM PHOSPHIDE (UNII: A360RQX9W2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XYLITOL (UNII: VCQ006KQ1E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70766-012-01	144 in 1 BOX	01/04/2024
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:70766-012-02	5 in 1 CARTON	01/04/2024
2		24 in 1 BOX
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:70766-012-06	480 in 1 BOX	01/04/2024
3		28 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:70766-012-03	144 in 1 BOX	01/04/2024
4		50 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:70766-012-04	72 in 1 BOX	01/04/2024
5		100 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:70766-012-05	144 in 1 BOX	01/04/2024
6		100 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:70766-012-07	72 in 1 BOX	01/04/2024
7		120 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:70766-012-08	144 in 1 BOX	01/04/2024
8		120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	01/04/2024

Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)

Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)