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Colgate

Mission Hills S.A de C.V

Colgate Fluoride Toothpaste Monster High™ Mild Bubble Fruit


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% 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

sorbitol, water, hydrated silica, PEG-12, cellulose gum, sodium lauryl sulfate, flavor, sodium saccharin, mica, titanium dioxide, FD&C red no. 40, D&C red no. 33

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

Colgate ®
Fluoride Toothpaste

CLINICALLY PROVEN
Cavity & Enamel Protection

ADA
Accepted

American
Dental
Association
®

Toothpaste

NET WT
4.6 OZ
(130 g)

MONSTER HIGH

Mild BUBBLE FRUIT ®

Colgate

Colgate

SODIUM FLUORIDE PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65954-070
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
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
saccharin sodium
MICA
titanium dioxide
FD&C RED NO. 40
D&C RED NO. 33

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-070-46 130 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-06-04


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Be sure to consult your doctor before taking any medication!
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