KIRKLAND SIGNATURE PRO-COMPLETE PLUS WHITENING- sodium fluoride paste
Costco Wholesale Corporation

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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Drug Facts

Active ingredient

Sodium fluoride (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

When using this product,

if irritation occurs discontinue use

Keep out of reach of children under 6 years of age. (for 63981-100)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age. (for 63981-101)

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 years of age and older:

•: apply toothpaste onto a toothbrush
•: brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
•: to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.

•

children under 2 years consult a dentist or doctor.

Other information

•: store below 30°C (86°F)

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8; sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, sodium hydroxide, sodium saccharin, sodium benzoate, blue 1 lake

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8; sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, blue 1

Questions or comments?

call toll-free 1-888-511-0023

Principal Display Panel

NDC 63981-100-01

KIRKLAND Signature

FLUORIDE TOOTHPASTE

PRO COMPLETE

plus WHITENING

fresh mint

NET WT. 7.5 OZ (212.6g)

FIGHTS CAVITIES

FIGHTS PLAQUE*

HEALTHY GUMS*

FRESHENS BREATH

REMOVES SURFACE STAINS

Kirkland Signature Pro Complete Toothpaste plus Whitening offers you and your family Pro Complete protection.

•: Fights Plaque*
•: Fights Cavities
•: Freshens Breath
•: Removes Surface Stains
•: Promotes Healthy Gums*

*with regular brushing

Every Kirkland Signature product is guaranteed to meet or exceed the quality standards of the leading national brands. If you’re not completely satisfied, your money will be refunded.

ALWAYS FOLLOW THE LABEL

Distributed by:

Costco Wholesale Corporation

P.O. Box 34535, Seattle, WA 98124-1535, U.S.A.

1-800-774-2678

www.costco.com

103595XA

Kirkland Pro Complete plus whitening 7.5oz (212.6g) carton

Principal Display Panel

NDC 63981-101-01

KIRKLAND Signature

FLUORIDE TOOTHPASTE

PRO COMPLETE

plus WHITENING

fresh mint

NET WT. 7.5 OZ (212.6g)

FIGHTS CAVITIES

FIGHTS PLAQUE*

HEALTHY GUMS*

FRESHENS BREATH

REMOVES SURFACE STAINS

Kirkland Signature Pro Complete Toothpaste plus Whitening offers you and your family Pro Complete protection.

•: Fights Plaque*
•: Fights Cavities
•: Freshens Breath
•: Removes Surface Stains
•: Promotes Healthy Gums*

*with regular brushing

Every Kirkland Signature product is guaranteed to meet or exceed the quality standards of the leading national brands. If you’re not completely satisfied, your money will be refunded.

ALWAYS FOLLOW THE LABEL

Distributed by:

Costco Wholesale Corporation

P.O. Box 34535, Seattle, WA 98124-1535, U.S.A.

1-800-774-2678

www.costco.com

105291XA

KIRKLAND SIGNATURE PRO-COMPLETE PLUS WHITENING
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63981-100
Route of Administration	ORAL

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
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	BLUE (blue and white stripes)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63981-100-01	1 in 1 CARTON	09/13/2010	06/30/2018
1		212.6 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	09/13/2010	06/30/2018

KIRKLAND SIGNATURE PRO-COMPLETE PLUS WHITENING
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63981-101
Route of Administration	ORAL

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
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE (blue and white stripes)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63981-101-01	1 in 1 CARTON	09/01/2016	07/31/2018
1		212.6 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	09/01/2016	07/31/2018

Labeler - Costco Wholesale Corporation (103391843)

Revised: 5/2018

Document Id: 13549a58-e052-450e-a3a7-53559acddd17

Set id: 4d8720df-35e6-4334-9f37-dda4dbeca60b

Version: 9

Effective Time: 20180514

Costco Wholesale Corporation