COLGATE ZERO STRONG TEETH- sodium fluoride mouthwash

Colgate Zero Strong Teeth by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

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:

• use twice a day after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without supervision

Children under 6 years of age:

consult a dentist or doctor

Other information

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

Inactive ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Poloxamer 338, PEG-40 Hydrogenated Castor Oil, Flavor, Phosphoric Acid, Disodium Phosphate, Potassium Sorbate, Cetylpyridinium Chloride, Rebaudioside A.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 515 mL Bottle Label

Colgate®

zero

STRENGTHENS ENAMEL

0% alcohol

0% dyes

0% artificial flavors

Strong Teeth

natural
peppermint

Anticavity Fluoride Mouthwash

17.4 FL OZ (1.08 PT) 515 mL

P9937238

IMPORT-
ANT:
Read
directions

INGREDIENTS AND APPEARANCE

COLGATE ZERO STRONG TEETH 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-881
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLOXAMER 338 (UNII: F75JV2T505)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-881-56	515 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/12/2019

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-881)