COLGATE® 2IN1 OXYGEN WHITENING COOL MINT FLUORIDE

COLGATE by

Drug Labeling and Warnings

COLGATE by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE  2IN1 OXYGEN WHITENING COOL MINT FLUORIDE- sodium monofluorophosphate gel, 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® 2IN1 OXYGEN WHITENING COOL MINT FLUORIDE

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of cavities

Warnings

Keep out of the 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, propylene glycol, water, sorbitol, sodium lauryl sulfate, flavor, sodium bicarbonate, sodium hydroxide, sodium saccharin, cellulose gum, carrageenan, calcium peroxide, FD&C blue no. 1

Questions?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130g Bottle Label

2 in 1
Toothpaste
& Mouthwash

Colgate®
Fluoride Toothpaste

Cleans Teeth & Freshens Breath

Oxygen
Whitening

Cool Mint

NET WT 4.6 OZ(130g)
LIQUID GEL

COLGATE   2IN1 OXYGEN WHITENING COOL MINT FLUORIDE
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-372
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
SORBITOL (UNII: 506T60A25R)	634.68 mg  in 1 g
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
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: 65954-372-81	130 g in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/26/2011

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

Revised: 4/2019

Document Id: a826c83c-8aa5-4006-90fc-fe24e1360190

34390-5

Set id: 58360dd2-e670-434e-a67e-85aa4a5db2a8

Version: 3

Effective Time: 20190410

 

Mission Hills S.A de C.V