COLGATE MAX WHITE CRYSTAL MINT- sodium fluoride gel, dentifrice
Mission Hills S.A de C.V
Reference Label Set Id: 2a742816-f5e9-427a-86fd-d728408e4aa4
Reference Label Set Id: c12ca704-951f-436d-8a6b-18494e149d80

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® Max White® Crystal Mint 6.0 Fluoride Toothpaste

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, FD&C yellow no. 5

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

FRESHENS BREATH
MaxWhite®
WITH
MINI
BRIGHT STRIPS

Whitens to Help Teeth Stay Bright*

NET WT 6.0 OZ (170 g)

CRYSTAL MINT

Principal Display Panel - 170 g Tube Carton

COLGATE MAX WHITE CRYSTAL MINT
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-042
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)	564.38 mg in 1 g
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)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	BLUE (LIGHT BLUE WITH WHITE FILM)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65954-042-60	1 in 1 CARTON	01/27/2009
1		170 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:65954-042-78	1 in 1 CARTON	01/27/2009
2		221 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:65954-042-85	1 in 1 CARTON	01/27/2009
3		204 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:65954-042-79	1 in 1 CARTON	01/27/2009
4		79 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:65954-042-58	1 in 1 CARTON	01/27/2009
5		70 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 FINAL	part355	01/27/2009

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

Revised: 4/2019

Document Id: 674b1b08-0911-4ab3-b651-d359c786f9c9

Set id: 5372cd99-37d7-4415-802b-0671d691ec86

Version: 4

Effective Time: 20190410

Mission Hills S.A de C.V