COLGATE ESSENTIALS- sodium monofluorophosphate paste, dentifrice

Colgate Essentials by

Drug Labeling and Warnings

Colgate Essentials 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 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

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

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

INGREDIENTS AND APPEARANCE

COLGATE ESSENTIALS 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-974
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-974-61	1 in 1 CARTON	04/09/2018
1		172 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-974-46	1 in 1 CARTON	10/12/2018
2		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 not final	part356	04/09/2018

Labeler - Colgate-Palmolive Company (001344381)