COLGATE ZERO CLEAR SPEARMINT- sodium fluoride gel, 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® ZERO CLEAR GEL SPEARMINT

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.15% 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, Xylitol, PEG-12, Cellulose Gum, Flavor, Sodium Lauryl Sulfate, Benzyl Alcohol, Rebaudioside A.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

NEW

Colgate®
Anticavity Fluoride Toothpaste

zero
0% ARTIFICIAL
FLAVORS • SWEETENERS
PRESERVATIVES • COLORS

CLEAR GEL
SPEARMINT

NET WT
4.6 OZ (130g)

STRENGTHENS ENAMEL AND PROVIDES CLINICALLY PROVEN CAVITY PROTECTION

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton
COLGATE ZERO CLEAR SPEARMINT 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-984
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) 680 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
Product Characteristics
ColorWHITE (Transparent slightly beige) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-984-461 in 1 CARTON10/02/2019
1130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/02/201907/01/2022
Labeler - Colgate-Palmolive Company (001344381)

Revised: 12/2019
Document Id: 809619e1-b99a-40ce-bdff-8a2ff1b0e032
Set id: a7b1e908-e2e8-4c42-bfd0-bfcf001eaf1e
Version: 2
Effective Time: 20191220
 
Colgate-Palmolive Company