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COLGATE

Mission Hills S.A de C.V

COLGATE 2IN1 TOOTHPASTE AND MOUTHWASH WHITENING STAIN LIFTERS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of 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 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, cocamidopropyl betaine, cellulose gum, xanthan gum, titanium dioxide

Questions?

Call toll-free 1-800-468-6502

Dist.
by:

CP COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

2 in 1

Toothpaste
& Mouthwash

Colgate ®
Fluoride Toothpaste

Cleans Teeth & Freshens Breath

Whitening
with Stain Lifters

NET WT 4.6 OZ (130 g)
LIQUID GEL

COLGATE

COLGATE

SODIUM FLUORIDE GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65954-038
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 1.1 mg

Inactive Ingredients

Ingredient Name Strength
sorbitol
water
GLYCERIN
HYDRATED SILICA
SODIUM LAURYL SULFATE
COCAMIDOPROPYL BETAINE
SODIUM PYROPHOSPHATE
saccharin sodium
titanium dioxide
CARBOXYMETHYLCELLULOSE SODIUM
XANTHAN GUM

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-038-81 130 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-07-26


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Be sure to consult your doctor before taking any medication!
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