International First Class Kit

Drug Labeling and Warnings

Drug Details [pdf]

INTERNATIONAL FIRST CLASS KIT- sodium fluoride 
Buzz Products (HK) Co. Limited

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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International First Class Kit

Drug Facts

Active ingredient

Sodium fluoride 0.243%

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

crest-01
INTERNATIONAL FIRST CLASS  KIT
sodium fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70402-011
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70402-011-011 in 1 KIT; Type 0: Not a Combination Product04/30/201812/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 24 g
Part 1 of 1
CREST 3D WHITE  BRILLIANCE
sodium fluoride paste, dentifrice
Product Information
Item Code (Source)NDC: 37000-873
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)  
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)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37000-873-011 in 1 CARTON
124 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 finalpart35504/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart355B04/30/201812/18/2018
Labeler - Buzz Products (HK) Co. Limited (663516515)

Revised: 12/2018