DINOSAUR- sodium fluoride paste

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]

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

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

PRINCIPAL DISPLAY PANEL

24g NDC: 71775-070-54

120g NDC: 71775-070-52

24g NDC: 71775-070-55

120g NDC: 71775-070-53

INGREDIENTS AND APPEARANCE

DINOSAUR 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71775-070
Route of Administration	DENTAL

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

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: 71775-070-54	24 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2021
2	NDC: 71775-070-52	120 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2021
3	NDC: 71775-070-55	24 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2021
4	NDC: 71775-070-53	120 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/22/2021

Labeler - LMZ (654623156)

Establishment
Name	Address	ID/FEI	Business Operations
LMZ		654623156	manufacture(71775-070)