COLGATE REVITALIZING WHITE- sodium monofluorophosphate paste, dentifrice

Drug Labeling and Warnings

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, Sorbitol, Hydrated Silica, Calcium Pyrophosphate, Glycerin, PEG-12, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Xanthan Gum, Charcoal Powder, Sodium Saccharin, Cocamidopropyl Betaine, Blue 1, Red 40, Yellow 5.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

REVITALIZING
WHITE

whitening toothpaste
with
activated charcoal

Recyclable
Tube

NET WT 4.6 OZ (130 g)

FRESH MINT

INGREDIENTS AND APPEARANCE

COLGATE REVITALIZING WHITE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-017
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 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
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 (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
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: 35000-017-46	1 in 1 CARTON	10/12/2018
1		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 DRUG	M021	04/09/2018

Labeler - Colgate-Palmolive Company (001344381)

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