COLGATE BAKING SODA AND PEROXIDE WHITENING BRISK MINT- sodium monofluorophosphate paste, dentifrice

COLGATE by

Drug Labeling and Warnings

COLGATE 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% (0.14% 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

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 130 g Carton

Colgate®
Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Baking Soda
& Peroxide
Whitening

Cleans Deep and
Whitens Teeth

Brisk Mint®Paste

INGREDIENTS AND APPEARANCE

COLGATE   BAKING SODA AND PEROXIDE WHITENING BRISK MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-959
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
GLYCERIN (UNII: PDC6A3C0OX)	491.6 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-959-46	1 in 1 CARTON	08/20/2011
1		130 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-959-64	1 in 1 CARTON	08/20/2011
2		181 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-959-82	1 in 1 CARTON	08/20/2011
3		232 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-959-69	1 in 1 CARTON	08/20/2011
4		113 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-959-75	1 in 1 CARTON	08/20/2011
5		79 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 35000-959-60	1 in 1 CARTON	08/20/2011
6		170 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 35000-959-48	1 in 1 CARTON	08/20/2011
7		226 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 35000-959-58	1 in 1 CARTON	08/20/2011
8		70 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 35000-959-92	1 in 1 CARTON	08/20/2011
9		141 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 FINAL	part355	08/20/2011

Labeler - Colgate-Palmolive Company (001344381)