DENTAL KITS 2- sodium fluoride 
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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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Dental Kits 2

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.14% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warning

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

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, PEG-20M or PEG-23M, xanthan gum, sucralose, mica, titanium dioxide

Questions?

1-800-492-7378

Package Labeling:

LabelTube 2

DENTAL  KITS 2
sodium fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-086
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-086-001 in 1 KIT05/03/201712/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 24 g
Part 1 of 1
CREST 3D WHITE BRILLIANC 
sodium fluoride paste, dentifrice
Product Information
Item Code (Source)NDC:69491-081
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)  
POLYETHYLENE OXIDE 1000000 (UNII: HZ58M6D839)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-081-0024 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/03/201712/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/03/201712/01/2018
Labeler - Buzz Export Services Pty., Ltd. (747317902)

Revised: 11/2019
Document Id: 97285351-7867-0b52-e053-2a95a90a1b49
Set id: 5bbbd639-b510-4145-a98a-e23d3e7f2f98
Version: 5
Effective Time: 20191112
 
Buzz Export Services Pty., Ltd.