Dinosaur by LMZ Dinosaur Toothpaste

Dinosaur by

Drug Labeling and Warnings

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

Drug Details [pdf]

DINOSAUR- sodium fluoride paste 
LMZ

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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Dinosaur Toothpaste

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.

• Do not swallow.
• To minimize swallowing use a pea sized 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 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: 71775-071-54

120g NDC: 71775-071-52

DINOSAUR 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71775-071
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	24 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71775-071-54	24000 mg in 1 TUBE; Type 0: Not a Combination Product	11/30/2020
2	NDC: 71775-071-52	120000 mg in 1 TUBE; Type 0: Not a Combination Product	11/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/30/2020	01/09/2021

Labeler - LMZ (654623156)

Establishment
Name	Address	ID/FEI	Business Operations
LMZ		654623156	manufacture(71775-071)

Revised: 1/2021

Document Id: b86d9e00-da0c-1e46-e053-2995a90adbb6

34390-5

Set id: b56b4b99-aea9-5bf1-e053-2a95a90ad318

Version: 2

Effective Time: 20210108