COLGATE MAXFRESH ANTICAVITY FLUORIDE ELECTRIC MINT- sodium fluoride paste, dentifrice
Mission Hills, S.A de C.V

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® MaxFresh® Anticavity Fluoride Toothpaste Electric Mint™

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, flavor, sodium lauryl sulfate, cellulose gum, sodium saccharin, tetrasodium pyrophosphate, cocamidopropyl betaine, lactose monohydrate, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 79 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

Mind-Blowing Long-Lasting Freshness

NET WT 2.8 OZ (79 g)

with Micro-Cooling Beads
MaxFresh®
SHOCKWAVE ™

electric
mint™

WITH
WHITENING

NEW

Principal Display Panel - 79 g Tube Carton

COLGATE MAXFRESH ANTICAVITY FLUORIDE ELECTRIC MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-775
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65954-775-79	1 in 1 CARTON	10/31/2014
1		79 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:65954-775-60	1 in 1 CARTON	10/31/2014
2		170 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:65954-775-78	1 in 1 CARTON	10/31/2014
3		221 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:65954-775-58	1 in 1 CARTON	10/31/2014
4		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	10/31/2014

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

Revised: 4/2019

Document Id: 4a44ed58-71ea-4f32-bfef-bfae1cf50a28

Set id: 3448ae9f-c3aa-4bca-9d30-1172e932a6fc

Version: 3

Effective Time: 20190417

Mission Hills, S.A de C.V