Colgate® Sparkling White® Mint Zing Fluoride Toothpaste Gel

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  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)

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

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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

34390-5

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

Version: 5

Effective Time: 20190408