KIT 2- sodium fluoride kit

Kit 2 by

Drug Labeling and Warnings

Kit 2 by is a Otc medication manufactured, distributed, or labeled by Buzz Export Services Pty., Ltd., Zhejiang Baron Travel Product Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.16% 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 tweice a day or use as directed by a dentist 
• do not swallow
• to minimize swallowing use a pea-sized amount in children under 6 
• children under 2 yrs: ask a dentist

Inactive ingredients

glycerin, hydrated silica, sodium hexametaphosphate, water, 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

KIT 2 
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69491-080

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-080-00	1 in 1 TUBE	01/25/2017

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-081-00	24 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/24/2017

Labeler - Buzz Export Services Pty., Ltd. (747317902)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.		421290194	manufacture(69491-080, 69491-081)