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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Colgate® Sparkling White® Mint Zing Fluoride Toothpaste Gel

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 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, 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-068
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	502.85 mg in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65954-068-79	1 in 1 CARTON	03/01/2013
1		79 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:65954-068-69	1 in 1 CARTON	03/01/2013
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:65954-068-46	1 in 1 CARTON	03/01/2013
3		130 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:65954-068-64	1 in 1 CARTON	03/01/2013
4		181 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:65954-068-82	1 in 1 CARTON	03/01/2013
5		232 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:65954-068-60	1 in 1 CARTON	03/01/2013
6		170 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:65954-068-48	1 in 1 CARTON	03/01/2013
7		226 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:65954-068-58	1 in 1 CARTON	03/01/2013
8		70 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC:65954-068-92	1 in 1 CARTON	03/01/2013
9		141 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	03/01/2013

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

Revised: 4/2019

Document Id: a63c5bff-f3f1-4848-8211-2e8fd947704f

Set id: 56b96f8f-4f75-4762-ae2c-4064543e46d8

Version: 5

Effective Time: 20190408

Mission Hills S.A de C.V