SMILEGUARD JUST 4 ME- sodium fluoride paste

SmileGuard Just 4 Me by

Drug Labeling and Warnings

SmileGuard Just 4 Me by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh, Inc., The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMILEGUARD JUST 4 ME 
sodium fluoride paste

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Dr. Fresh, Inc. (078508990)

Establishment
Name	Address	ID/FEI	Business Operations
The Procter & Gamble Manufacturing Company		007130032	manufacture(64893-800)