COLGATE ESSENTIALS- sodium monofluorophosphate 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® Essentials™ Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.10% 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, calcium pyrophosphate, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, flavor, sodium lauryl sulfate, cellulose gum, sodium saccharin, charcoal powder, xanthan gum, cocamidopropyl betaine, blue 1, red 40, yellow 5

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

ESSENTIALS™
WITH CHARCOAL

Daily toothpaste removes stains and impurities
for whiter teeth and fresher breath

NET WT 4.6 OZ (130g)
ENAMEL SAFE
FRESH MINT

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

COLGATE ESSENTIALS
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-786
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.0 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	181.01 mg in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
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 FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65954-786-61	1 in 1 CARTON	04/09/2018
1		172 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:65954-786-46	1 in 1 CARTON	10/12/2018
2		130 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 not final	part356	04/09/2018

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

Revised: 10/2018

Document Id: 2f52894c-8cee-42ef-870f-5800bf5dbfd0

Set id: 01c205e0-8419-47a4-ba9e-403251966ed5

Version: 4

Effective Time: 20181017

Mission Hills S.A de C.V