COLGATE Great Regular Flavor description, usages, side effects, indications, overdosage, supplying and lots more!

COLGATE Great Regular Flavor

Mission Hills S.A de C.V

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
COLGATE Great Regular Flavor Fluoride Toothpaste

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against 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

dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

Colgate®
Fluoride Toothpaste

ADA
ACCEPTED
American
Dental
Association ®

NET WT 8.2 OZ (232 g)

Cavity
Protection

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

COLGATE Great Regular Flavor

SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65954-060
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 1.0 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM LAURYL SULFATE
water
GLYCERIN
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM PYROPHOSPHATE
saccharin sodium

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-060-20 24 in 1 TUBE
2 36.8 in 1 TUBE
3 113 in 1 TUBE
4 130 in 1 TUBE
5 NDC:65954-060-60 170 in 1 TUBE
6 181 in 1 TUBE
7 232 in 1 TUBE
8 NDC:65954-060-04 4.25 in 1 POUCH
9 79 in 1 TUBE
10 NDC:65954-060-93 99 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2005-11-05


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