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Church & Dwight Co., Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients
Sodium fluoride (0.24%)

Purpose

Purpose
Anticavity toothpaste

Uses

Use  aids in the prevention of dental decay

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    do not swallow    supervise children as necessary until capable of using without supervision

adults and children 2 years and older               brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years                                    instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years                                    ask a dentist or physician

Inactive ingredients  sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, red 33, red 40.

Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET

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                                                        Cleans, Whitens and Freshens

FRESHENING GEL with Mouthwash

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Sodium Fluoride GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-644
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 2.4 mg

Inactive Ingredients

Ingredient Name Strength
sorbitol
water
HYDRATED SILICA
PEG-8 STEARATE
SODIUM LAURYL SULFATE
ALCOHOL
CARBOXYMETHYLCELLULOSE SODIUM
SACCHARIN SODIUM DIHYDRATE
D&C RED NO. 33
FD&C RED NO. 40

Product Characteristics

Color
red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113.4 in 1 TUBE
2 170 in 1 TUBE
3 204 in 1 TUBE
4 226.8 in 1 TUBE
5 NDC:10237-644-80 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2001-03-01


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