COLGATE LUMINOUS CRYSTAL FLUORIDE- sodium fluoride gel, dentifrice

Colgate Luminous Crystal Fluoride by

Drug Labeling and Warnings

Colgate Luminous Crystal Fluoride 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against 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

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, mica, titanium dioxide, FD&C blue no.1

Questions or comments?

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Mexico
www.colgateluminous.com

PRINCIPAL DISPLAY PANEL - 113 g carton

Colgate®
Fluoride Toothpaste

ADA
Accepted
American
Dental
Association ®

NET WT 4.0 OZ (113 g)

LUMINOUS
Enamel Strengthening
CRYSTAL CLEAN MINT™

33%
FREE
3.0oz + 1.0oz

INGREDIENTS AND APPEARANCE

COLGATE LUMINOUS CRYSTAL FLUORIDE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-022
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	564.38 mg  in 1 g
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE (sky blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-022-69	1 in 1 CARTON
1		113 g in 1 TUBE
2	NDC: 65954-022-64	1 in 1 CARTON
2		181 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/03/2009

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