COLGATE ZERO CLEAR- sodium fluoride gel, dentifrice

Colgate Zero Clear by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

Sorbitol, Water, Hydrated Silica, Xylitol, PEG-12, Flavor, Cellulose Gum, Sodium Lauryl Sulfate, Benzyl Alcohol, Rebaudioside A.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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
PEPPERMINT

STRENGTHENS ENAMEL AND PROVIDES CLINICALLY PROVEN CAVITY PROTECTION

NET WT
4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

COLGATE ZERO CLEAR 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-985
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 FORM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BENZYL ALCOHOL (UNII: LKG8494WBH)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color	WHITE (Transparent slightly beige)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-985-46	1 in 1 CARTON	10/07/2019
1		130 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/07/2019

Labeler - Colgate-Palmolive Company (001344381)