GOBY PEPPERMINT- sodium fluoride paste 
BGLG, Inc.

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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Goby peppermint Toothpaste

Drug Facts

Active Ingredients

sodium fluoride, .24%
(0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Helps prevent cavities

Warning

Keep out of reach of children

under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply a pea-sized amount. Brush teeth thoroughly. Consult with a dentist or physician if needed.

Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, PEG-12, flavor, titanium dioxide, cellulose gum, sodium benzoate, sodium saccharin

Package Labeling:

Label

GOBY PEPPERMINT 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81788-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81788-001-0099 g in 1 TUBE; Type 0: Not a Combination Product05/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2021
Labeler - BGLG, Inc. (074391154)

Revised: 4/2021
Document Id: c0539abe-fa93-d4a6-e053-2a95a90a1975
Set id: c0541f32-f039-3630-e053-2a95a90a12d6
Version: 1
Effective Time: 20210419
 
BGLG, Inc.