PLAK SMACKER MINT BLAST- sodium fluoride paste

Plak Smacker by

Drug Labeling and Warnings

Plak Smacker by is a Otc medication manufactured, distributed, or labeled by LMZ. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium Fluoride 0.243% (equivalent to 0.13% w/v fluoride ion)

Purpose

Anti-cavity

Uses

Aids in the prevention of cavities

Warnings

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

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

Directions

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 a physician.

Children 2 to 6 years: To minimize swallowing use a pea sized amount. Supervise children's brushing until good habits are established.

Children under 2 years: Ask a dentist or a physician.

Inactive Ingredients

Sorbitol, Silica, Water, PEG-8, Sodium lauryl sulfate, Flavor, Titanium dioxide, Cellulose gum, Trisodium phosphate, Sodium saccharin, Xanthan gum, Benzyl alcohol, Xylitol, CI 42090

Principal Display Panel

28 g NDC: 71775-080-01

INGREDIENTS AND APPEARANCE

PLAK SMACKER  MINT BLAST
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71775-080
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	130 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71775-080-01	28 g in 1 TUBE; Type 0: Not a Combination Product	03/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/18/2021

Labeler - LMZ (654623156)

Establishment
Name	Address	ID/FEI	Business Operations
LMZ		654623156	manufacture(71775-080)