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Colgate

Mission Hills, S.A. de C.V.

Colgate BSPW OxyBub Frosty Mint Fluoride Toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (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

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

Colgate ®
Fluoride Toothpaste

NET WT 8.2 OZ (232 g)

Baking Soda
& Peroxide
Whitening

Cleans Deep and
Whitens Teeth

Frosty Mint ® Stripe Gel

Colgate

Colgate

SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65954-768
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 7.6 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
HYDRATED SILICA
water
SODIUM BICARBONATE
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
SODIUM HYDROXIDE
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
SACCHARIN SODIUM DIHYDRATE
CALCIUM PEROXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
titanium dioxide

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 232 in 1 TUBE
2 NDC:65954-768-82 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-08-20


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Be sure to consult your doctor before taking any medication!
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