DINOSAUR- sodium fluoride paste 
LMZ
Reference Label Set Id: b196665d-b579-d0bc-e053-2a95a90a78e1

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Plak Smacker

Active Ingredients

Sodium Fluoride 0.24% Anti-Cavity
(0.10% w/w fluoride ion) Toothpaste

Purpose

Anti-Cavity
Toothpaste

Use

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.

Do Not Use

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

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 physician.

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Sodium Benzoate, Xylitol, Trisodium Phosphate, Xanthan Gum, Acid Blue 9, Allura Red AC

Questions or comments?

1-800-558-6684

24g NDC: 71775-070-54 24000 mg Dinosaur

120g NDC: 71775-070-52

120000 mg Dinosaur

24g NDC: 71775-070-55

Great Shark 24g

120g NDC: 71775-070-53

Shark 120g

DINOSAUR 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71775-070
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION100 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
SORBITOL (UNII: 506T60A25R)  
ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
CLINOPODIUM CHINENSE WHOLE (UNII: 29350ODC51)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71775-070-5424 g in 1 TUBE; Type 0: Not a Combination Product01/22/2021
2NDC:71775-070-52120 g in 1 TUBE; Type 0: Not a Combination Product01/22/2021
3NDC:71775-070-5524 g in 1 TUBE; Type 0: Not a Combination Product04/30/2021
4NDC:71775-070-53120 g in 1 TUBE; Type 0: Not a Combination Product04/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/22/2021
Labeler - LMZ (654623156)
Establishment
NameAddressID/FEIBusiness Operations
LMZ654623156manufacture(71775-070)

Revised: 5/2021
Document Id: c1491f6d-3400-f38c-e053-2a95a90acf0e
Set id: bb9ef774-370c-1479-e053-2995a90a525a
Version: 2
Effective Time: 20210501
 
LMZ