DELTA ONE 2019 TUMI COLLINS AMENITY WITH CREST COMPLETE WHITENING SCOPE- sodium fluoride
Buzz Export Services Pty Ltd

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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DELTA ONE 2019 - TUMI COLLINS AMENITY KIT With Crest Complete Whitening + Scope

Drug Facts

Active ingredients

Sodium fluride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of the reach of children under 6 years 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 of 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

sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Questions ?

1-800-492-7378

DELTA ONE 2019 - TUMI COLLINS AMENITY KIT With Crest Complete Whitening + Scope (69491-220-00)

Kit

CREST COMPLETE MULTI-BENEFIT WHITENING PLUS SCOPE 24g (37000-020-01)

Label

DELTA ONE 2019 TUMI COLLINS AMENITY WITH CREST COMPLETE WHITENING SCOPE
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69491-220

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69491-220-00	1 in 1 KIT	07/01/2019

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

Part 1 of 1

CREST COMPLETE MULTI-BENEFIT WHITENING PLUS SCOPE
sodium fluoride paste, dentifrice

Product Information
Item Code (Source)	NDC:37000-020
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-020-01	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	07/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/01/2019

Labeler - Buzz Export Services Pty Ltd (747317902)