COLGATE  SPARKLING WHITE MINT ZING- 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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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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask 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, FD&C blue no. 1, D&C yellow no. 10

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

Colgate®
Fluoride Toothpaste

Baking Soda
SPARKLING
WHITE®

Whitens & Helps Protect
Teeth from Stains

Mint Zing
gel

NET WT 4.6 OZ (130 g)

Principal Display Panel - 130 g Tube Carton
COLGATE   SPARKLING WHITE MINT ZING
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-068
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN502.85 mg  in 1 g
HYDRATED SILICA 
WATER 
SODIUM BICARBONATE 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
SODIUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-068-791 in 1 CARTON
179 g in 1 TUBE
2NDC:65954-068-691 in 1 CARTON
2113 g in 1 TUBE
3NDC:65954-068-461 in 1 CARTON
3130 g in 1 TUBE
4NDC:65954-068-641 in 1 CARTON
4181 g in 1 TUBE
5NDC:65954-068-821 in 1 CARTON
5232 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/01/2013
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 03/2013
Document Id: 50ebb209-0824-47f5-9e56-ddb28d1811ca
Set id: 56b96f8f-4f75-4762-ae2c-4064543e46d8
Version: 1
Effective Time: 20130313
 
Mission Hills S.A de C.V