NDC Code(s) : 63981-100-01, 63981-101-01
Packager : Costco Wholesale Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KIRKLAND SIGNATURE PRO-COMPLETE sodium fluoride PASTE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63981-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63981-100-011 in 1 CARTON 13/09/2010
1212.6 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 09/13/2010 06/30/2018
KIRKLAND SIGNATURE PRO-COMPLETE sodium fluoride PASTE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63981-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63981-101-011 in 1 CARTON 09/01/2016
1212.6 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 09/01/2016 07/31/2018

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 Pro Complete plus whitening 7.5oz (212.6g) carton