Fraiche Kids Paste, Bubble Gum Flavor by True Marker Pharmaceuticals, Inc. Drug Facts

Fraiche Kids Paste, Bubble Gum Flavor by

Drug Labeling and Warnings

Fraiche Kids Paste, Bubble Gum Flavor by is a Otc medication manufactured, distributed, or labeled by True Marker Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRAICHE KIDS PASTE, BUBBLE GUM FLAVOR- sodium fluoride paste 
True Marker Pharmaceuticals, Inc.

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Drug Facts

Active Ingredient 

0.24% w/w Sodium Fluoride

Purpose

Anti-cavity

Uses

 Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than the recommended amount of the paste used for brushing is
accidentally swallowed, get medical help or contact the Poison Control Center right away. In case of an allergic reaction, stop use, rinse mouth with water and seek medical advice.

Directions

For adults and children 2 years of age or older, apply a small peasized amount of FRAICHE Kids dental gel to your toothbrush. For best results,

brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use.

For children under 2 years of age, consult a dentist or physician.

Other information

  • Store at controlled room temperature, 68-77°F (20-25°C).
  • Do not use if safety seal is broke or missing.

Inactive Ingredients

Pure Water, Glycerol, Sorbitol, CMC-NA, Propylene Glycol, Silicon Dioxide, Titanium Dioxide, Xylitol, Phosphoric Acid, Flavoring, Sodium
Saccharin, Ethyl P-hydroxybenzoate, Propyl P-hydroxybenzoate, Butyl P-hydroxybenzoate, Sodium-N-lauroyl Sarcosinate.

Questions or Comments?

Call 1-888-811-2634
www.truemarkerpharma.com

Product label

image descriptionimage description

FRAICHE KIDS PASTE, BUBBLE GUM FLAVOR 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83592-803
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ETHYLPARABEN POTASSIUM (UNII: 528JBB2994)  
BUTYL SALICYLATE (UNII: QPR9LM8VZO)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83592-803-461 in 1 BOX06/20/202412/01/2024
146 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02106/20/202412/01/2024
Labeler - True Marker Pharmaceuticals, Inc. (119046582)

Revised: 11/2024