COLGATE ULTRA FRESH- sodium fluoride paste, dentifrice 
Colgate-Palmolive Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate® Ultra Fresh

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Cellulose Gum, Sodium Saccharin, Xanthan Gum, Blue 1, Yellow 5.

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 62 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

ULTRA
FRESH

Freshens breath + Fights plaque
gel

NET WT 2.2 OZ (62 g)

PRINCIPAL DISPLAY PANEL - 62 g Tube Carton
COLGATE ULTRA FRESH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-991
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9) 220 mg  in 1 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-991-981 in 1 CARTON10/16/2020
162 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/16/2020
Labeler - Colgate-Palmolive Company (001344381)

Revised: 10/2020
Document Id: 0122c6a6-066a-4459-8451-c224e4329261
Set id: 4a876472-f33c-4241-8d06-ae3d6da456e8
Version: 1
Effective Time: 20201019
 
Colgate-Palmolive Company