NDC Code(s) : 0126-0032-46
Packager : Colgate Oral Pharmaceuticals, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDE RINSE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0126-0032
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION2 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
SODIUM PHOSPHATE(UNII: SE337SVY37)
POLOXAMER 338(UNII: F75JV2T505)
POLYSORBATE 20(UNII: 7T1F30V5YH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PHOSPHORIC ACID(UNII: E4GA8884NN)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0126-0032-46500 mL in 1 BOTTLE Type 0: Not a Combination Product01/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH DRUG M021 01/12/2011

LABELER - Colgate Oral Pharmaceuticals, Inc.(968801118)

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

Colgate®
Anticavity Fluoride Rinse

Ortho
Defense®

Phos • Flur®

Sodium Fluoride Acidulated
Phosphate Solution

IDEAL PROTECTION
WHILE WEARING BRACES

  • ✓ORTHODONTIST RECOMMENDED
  • ✓HELPS STRENGTHEN ENAMEL
  • ✓HELPS PREVENT CAVITIES

16.9 FL OZ
(1.05 PT)
500 mL

MINT

ADA
Accepted
American
Dental
Association ®

IMPORTANT: Read
directions for proper use

P9933378

Protection between Brushings

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label