KIDS CREST  SESAME STREET- sodium fluoride gel, dentifrice 
Procter & Gamble Manufacturing Company

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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Drug Facts

Active ingredient

Sodium fluoride 0.243%

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, sodium phosphate, sodium saccharin, carbomer, mica, titanium dioxide, red 40

Questions?

1-800-255-8447

Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

KID'S
Crest®

123
SESAME STREET®

LIQUID GEL

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 4.6 OZ (130 g)

99607546

Principal Display Panel - 130 g Bottle Label
KIDS CREST   SESAME STREET
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-821
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM PHOSPHATE 
SACCHARIN SODIUM DIHYDRATE 
MICA 
TITANIUM DIOXIDE 
FD&C RED NO. 40 
Product Characteristics
ColorRED (with sparkles) Score    
ShapeSize
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-821-04130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/13/2010
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIBusiness Operations
Teva Pharmaceuticals USA Inc003237963MANUFACTURE(37000-821)

Revised: 12/2011
Document Id: 98125844-a13a-41fc-851b-9ac5f9d9ca93
Set id: d5bb9565-1ddd-466b-aa7b-e95ca31cdef3
Version: 1
Effective Time: 20111207
 
Procter & Gamble Manufacturing Company