SMILEGUARD JUST 4 ME- sodium fluoride paste
Dr. Fresh, LLC

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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SmileGuard Just 4 Me Kit

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anti-cavity toothpaste

Uses

Helps prevent against cavities

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Keep out of the reach of children under 6 years of age.

Directions

•: Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day as directed by a dentist or physician.
•: Do not swallow
•: To minimize swallowing, use a pea-sized amount for children under 6
•: Supervise children's brushing until good habits are established.
•: Children under 2 years: Ask a dentist

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Trisodium Phosphate, Sodium Lauryl Sulfate, Sodium Phosphate, Xanthan Gum, Flavor, Sodium Saccharin, Carbomer 956, Mica, Titanium Dioxide, Blue 1

Questions?

1-800-492-7378; www.crest.com

SMILEGUARD JUST 4 ME
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-800
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PHOSPHATE ION (UNII: NK08V8K8HR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-800-01	1 in 1 POUCH	08/17/2011	12/31/2015
1		24 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/17/2011	12/31/2015

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 04e6ef95-c386-4294-829f-f1945265d2c6

Set id: 6c664c11-5c2b-4a95-8494-c9e2dbc3e64c

Version: 4

Effective Time: 20210923

Dr. Fresh, LLC