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KIRKLAND SIGNATURE PRO-COMPLETE plus WHITENING

Medically reviewed on May 14, 2018

Dosage form: paste
Ingredients: SODIUM FLUORIDE 1.5mg in 1g
Labeler: Costco Wholesale Corporation
NDC Code: 63981-100

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.

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
Product Characteristics
ColorBLUE (blue and white stripes) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-100-011 TUBE in 1 CARTON
1212.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/13/201006/30/2018
KIRKLAND SIGNATURE PRO-COMPLETE  PLUS WHITENING
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
XANTHAN GUM 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUE (blue and white stripes) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-101-011 TUBE in 1 CARTON
1212.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/201607/31/2018
Labeler - Costco Wholesale Corporation (103391843)

 
Costco Wholesale Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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