Colgate RE renew by Colgate-Palmolive Company Colgate® RE renew

Colgate RE renew by

Drug Labeling and Warnings

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

Drug Details [pdf]

COLGATE RE RENEW- sodium fluoride paste, dentifrice 
Colgate-Palmolive Company

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Colgate® RE renew

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 the child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Calcium Pyrophosphate, PEG-12, Tetrapotassium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Potassium Hydroxide, Cellulose Gum, Phosphoric Acid, Xanthan Gum, Cocamidopropyl Betaine, Sodium Saccharin.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 107 g Tube Label

Colgate®

re:

re:new

whitening

fresh mint &
micro-polishers

anticavity fluoride toothpaste

NET WT 3.8 OZ (107 g)

P18133472

COLGATE RE RENEW 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-744
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
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
PHOSPHORIC ACID (UNII: E4GA8884NN)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-744-59	107 g in 1 TUBE; Type 0: Not a Combination Product	08/07/2021	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	08/07/2021	12/31/2024

Labeler - Colgate-Palmolive Company (001344381)

Revised: 9/2024

Document Id: 9e92d088-6023-4eff-b010-214556b937e1

34390-5

Set id: 679ffbd0-a4e1-9d03-1c88-1c4713b92a34

Version: 2

Effective Time: 20240927