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

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth by

Drug Labeling and Warnings

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth by is a Otc medication manufactured, distributed, or labeled by Yangzhou ONE & ONLY Personal Care Products Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

SODIUM FLUORIDE   0.24% (0.11 w/v Fluoride ion)

<text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text>

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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: 85162-003
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85162-003-01	144 in 1 BOX	01/16/2025
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 85162-003-02	5 in 1 CARTON	01/16/2025
2		24 in 1 BOX
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 85162-003-06	480 in 1 BOX	01/16/2025
3		28 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 85162-003-03	144 in 1 BOX	01/16/2025
4		50 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 85162-003-04	72 in 1 BOX	01/16/2025
5		100 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 85162-003-05	144 in 1 BOX	01/16/2025
6		100 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 85162-003-07	72 in 1 BOX	01/16/2025
7		120 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 85162-003-08	144 in 1 BOX	01/16/2025
8		120 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	01/16/2025

Labeler - Yangzhou ONE & ONLY Personal Care Products Co., LTD (458091296)

Registrant - Yangzhou ONE & ONLY Personal Care Products Co., LTD (458091296)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou ONE & ONLY Personal Care Products Co., LTD		458091296	manufacture(85162-003)