COLGATE MAXFRESH WITH MINI BREATH COOL MINT- sodium fluoride paste, dentifrice

Colgate MaxFresh with Mini Breath Cool Mint by

Drug Labeling and Warnings

Colgate MaxFresh with Mini Breath Cool Mint by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Colgate-Palmolive. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

MaxFresh®
with WHITENING

BREATH STRIPS

FRESHNESS THAT LASTS FOR HOURS!

NET WT 6.0 OZ (170 g)

COOL MINT

INGREDIENTS AND APPEARANCE

COLGATE MAXFRESH WITH MINI BREATH COOL MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-014
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-014-99	1 in 1 CARTON	09/23/2013
1		53 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-014-60	1 in 1 CARTON	09/23/2013
2		170 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-014-34	2 in 1 CARTON	09/23/2013
3		170 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-014-78	1 in 1 CARTON	09/23/2013
4		221 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-014-01	1 in 1 CARTON	09/23/2013
5		28 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 35000-014-79	1 in 1 CARTON	09/23/2013
6		70 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 35000-014-70	1 in 1 CARTON	11/30/2016
7		215 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	09/23/2013

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-014)