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

DELTA ONE 2019 TUMI COLLINS AMENITY With Crest Complete Whitening Scope by

Drug Labeling and Warnings

DELTA ONE 2019 TUMI COLLINS AMENITY With Crest Complete Whitening Scope by is a Otc medication manufactured, distributed, or labeled by Buzz Export Services Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

CREST COMPLETE MULTI-BENEFIT WHITENING PLUS SCOPE 24g (

37000-020-01)

INGREDIENTS AND APPEARANCE

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Buzz Export Services Pty Ltd (747317902)