Colgate Ultra Protect by Colgate-Palmolive Company Colgate® Ultra Protect

Colgate Ultra Protect by

Drug Labeling and Warnings

Colgate Ultra Protect by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE ULTRA PROTECT- sodium fluoride paste, dentifrice 
COLGATE PALMOLIVE COMPANY

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Colgate® Ultra Protect

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.

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

NET WT 2.2 OZ (62 g)

ULTRA
PROTECT

Fights cavities + Fortifies enamel gel

PRINCIPAL DISPLAY PANEL - 62 g Tube Carton
COLGATE ULTRA PROTECT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-993
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 (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-993-981 in 1 CARTON10/16/202012/31/2023
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 DRUGM02110/16/202012/31/2023
Labeler - COLGATE PALMOLIVE COMPANY (001344381)
Registrant - Colgate-Palmolive Company (001344381)

Revised: 12/2019
Document Id: ad48d13c-4ca7-4b92-a3c5-65c210bfa39f
Set id: 193ee950-f97a-416a-8812-29b03dfd570c
Version: 2
Effective Time: 20191210