COLGATE ENAMEL HEALTH MOUTHWASH- sodium fluoride rinse 
Colgate-Palmolive Company

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Colgate® Enamel Health Mouthwash

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Uses

aids in the prevention of dental cavities

Warnings

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

Children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, cetylpyridinium chloride, disodium phosphate, potassium sorbate, sucralose, FD&C green no. 3

Other Information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

NEW

ALCOHOL FREE

Colgate®
Anticavity Fluoride Mouthwash

ENAMEL
HEALTH

STRENGTHENS ENAMEL EVEN
WHERE BRUSHING MAY MISS

WITH FLUORIDE

HELPS REPLENISH NATURAL CALCIUM
BACK INTO ENAMEL
REVERSES ENAMEL SOFTENING TO HELP
PREVENT CAVITIES
FRESHENS BREATH

SPARKLING FRESH MINT

33.8 FL OZ
(1.05 QT)
1 L

IMPORTANT:
Read directions
for proper use

P9903598

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
COLGATE ENAMEL HEALTH MOUTHWASH 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-728
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLOXAMER 338 (UNII: F75JV2T505)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-728-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/201512/30/2024
2NDC:35000-728-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/201503/31/2026
3NDC:35000-728-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/201512/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02108/01/201503/31/2026
Labeler - Colgate-Palmolive Company (001344381)

Revised: 12/2023
Document Id: 63ca8818-e464-4966-86a8-04f4379bda3c
Set id: 7e264195-b024-440b-bafc-1d200694fdb0
Version: 9
Effective Time: 20231206
 
Colgate-Palmolive Company