COLGATE ADVANCED WHITENING FLUORIDE- sodium fluoride paste, dentifrice
Mission Hills S.A de C.V

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® Advanced Whitening Fluoride Toothpaste

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

water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, cocamidopropyl betaine, sodium saccharin, xanthan gum, sodium hydroxide, titanium dioxide

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

REMOVES SURFACE STAINS FOR WHITER TEETH

REVIVING
MINT

NET WT 6.0 OZ (170 g)

NEW

ADVANCED
WHITENING
WITH MICRO-POLISHING
ACTION

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

COLGATE ADVANCED WHITENING FLUORIDE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-778
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65954-778-60	1 in 1 CARTON	01/29/2015
1		170 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:65954-778-79	1 in 1 CARTON	01/29/2015
2		79 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:65954-778-58	1 in 1 CARTON	01/29/2015
3		70 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	01/29/2015	04/17/2019

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019

Document Id: b3eac549-5123-4763-a096-cebc35bbe06d

Set id: fdbe8ea4-ba02-4bfe-b619-bc8577142d9f

Version: 4

Effective Time: 20190417

Mission Hills S.A de C.V