Kit 2 (Sodium Fluoride) Kit [Buzz Export Services Pty., Ltd.] -

KIT 2 (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]
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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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	24 g

Part 1 of 1

CREST 3D WHITE BRILLIANC
sodium fluoride paste, dentifrice

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

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

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

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

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

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

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