INTERNATIONAL BUSINESS CLASS 1 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 Business Class #1 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 BUSINESS CLASS 1 KIT
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70402-013

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70402-013-01	1 in 1 KIT; Type 0: Not a Combination Product	04/30/2018	12/31/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 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 Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	white	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-873-01	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	04/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355B	04/30/2018	12/31/2021

Labeler - Buzz Products (HK) Co. Limited (663516515)

Revised: 11/2021

Document Id: d0d96639-d518-4dbb-e053-2995a90a06c5

Set id: 888f06e3-10ab-4439-8f16-1b7fdd39a336

Version: 3

Effective Time: 20211115

Buzz Products (HK) Co. Limited