COLGATE SPARKLING WHITE MINT ZING- sodium monofluorophosphate gel, dentifrice

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by COLGATE PALMOLIVE COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

COLGATE   SPARKLING WHITE MINT ZING
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-919
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: 35000-919-79	1 in 1 CARTON	03/01/2013
1		79 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-919-69	1 in 1 CARTON	03/01/2013
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-919-46	1 in 1 CARTON	03/01/2013
3		130 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-919-64	1 in 1 CARTON	03/01/2013
4		181 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-919-82	1 in 1 CARTON	03/01/2013
5		232 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 35000-919-60	1 in 1 CARTON	03/01/2013
6		170 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 35000-919-48	1 in 1 CARTON	03/01/2013
7		226 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 35000-919-58	1 in 1 CARTON	03/01/2013
8		70 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 35000-919-92	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 - Colgate-Palmolive Company (001344381)