Dinosaur: Package Insert and Label Information

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.

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: 71775-070-54

24000 mg Dinosaur
(click image for full-size original)

120g NDC: 71775-070-52

120000 mg Dinosaur
(click image for full-size original)

24g NDC: 71775-070-55

Great Shark 24g
(click image for full-size original)

120g NDC: 71775-070-53

Shark 120g
(click image for full-size original)
DINOSAUR
sodium fluoride paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71775-070
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 100 mg in 100 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400
WATER
HYDRATED SILICA
TITANIUM DIOXIDE
CARBOXYMETHYLCELLULOSE
SODIUM CHLORIDE
SACCHARIN SODIUM
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
SORBITOL
ZANTHOXYLUM NITIDUM ROOT
SODIUM BICARBONATE
SODIUM LAUROYL SARCOSINATE
BENZYL ALCOHOL
SODIUM COPPER CHLOROPHYLLIN
ETHYL MENTHANE CARBOXAMIDE
CLINOPODIUM CHINENSE WHOLE
CHONDRUS CRISPUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71775-070-54 24 g in 1 TUBE None
2 NDC:71775-070-52 120 g in 1 TUBE None
3 NDC:71775-070-55 24 g in 1 TUBE None
4 NDC:71775-070-53 120 g in 1 TUBE None
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 Operations
LMZ 654623156 manufacture (71775-070)

Revised: 05/2021 LMZ

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.