INTERNATIONAL BUSINESS CLASS 2 KIT- sodium fluoride kit

International Business Class 2 by

Drug Labeling and Warnings

International Business Class 2 by is a Otc medication manufactured, distributed, or labeled by Buzz Products (HK) Co. Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

INTERNATIONAL BUSINESS CLASS 2  KIT
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70402-014

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70402-014-01	1 in 1 KIT; Type 0: Not a Combination Product	04/30/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

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