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Colgate

Mission Hills S.A de C.V

Colgate Max Clean™ Effervescent mint™ Fluoride Toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of 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, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, methylcellulose, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

Colgate ®
Anticavity Fluoride Toothpaste

30% More Foam*
Cleans Tough to Reach Spaces

NET WT 6.0 OZ (170 g)

WITH WHITENING
MaxClean

SMARTFOAM ®

EFFERVESCENT MINT™

Colgate

Colgate

SODIUM FLUORIDE GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65954-381
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
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
POLOXAMER 407
SODIUM LAURYL SULFATE
XANTHAN GUM
COCAMIDOPROPYL BETAINE
SODIUM PYROPHOSPHATE
MICA
titanium dioxide
saccharin sodium
METHYLCELLULOSE (400 MPA.S)
FD&C BLUE NO. 1

Product Characteristics

Color
BLUE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.3 in 1 TUBE
2 170 in 1 TUBE
3 204 in 1 TUBE
4 221 in 1 TUBE
5 NDC:65954-381-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-03-18


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