Colgate Luminous Crystal Fluoride

Manufacturer: Mission Hills S.A. de C.V.
Effective date: 2013-04-29
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:40:56

Label at a glance#

ProductColgate Luminous Crystal Fluoride

Active ingredientSODIUM FLUORIDE

Label structure10 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-468-6502

Websitewww.colgateluminous.com

www.colgateluminous.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65954-022-64	2025-01-10	C162847	48780-1	9855d018-da93-cd31-e053-dbdaa90ab51a	Colgate ® Fluoride Toothpaste
65954-022-69	2025-01-10	C162847	48780-1	9855d018-da93-cd31-e053-dbdaa90ab51a	Colgate ® Fluoride Toothpaste
65954-022-64	2019-11-27	C162847	48780-1	9855d018-da93-cd31-e053-dbdaa90ab51a	Colgate ® Fluoride Toothpaste
65954-022-69	2019-11-27	C162847	48780-1	9855d018-da93-cd31-e053-dbdaa90ab51a	Colgate ® Fluoride Toothpaste

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	2
MICA	INACTIVE INGREDIENT	V8A1AW0880	2
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

Colgate Luminous Crystal Fluoride
SODIUM FLUORIDE
FLUORIDE ION
SORBITOL
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
COCAMIDOPROPYL BETAINE
SODIUM PYROPHOSPHATE
SACCHARIN SODIUM
MICA
TITANIUM DIOXIDE
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65954-022	65954-022-69, 65954-022-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
POLYETHYLENE GLYCOL 600	NL4J9F21N9	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
MICA	V8A1AW0880	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 253 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAVITREAL	0.5 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, EXTENDED RELEASE / ORAL	2.5 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED / ORAL	50 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM / BUCCAL		18 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE / DENTAL		249 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / BUCCAL	4 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION, SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / SOFT TISSUE		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE, FOR SUSPENSION / ORAL	15.63 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / ORAL		3480 mg	Exact identifier — unii candidate 44 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a2811e07-ff2c-4602-a5e0-b74439a78020			560d75e7-8b91-4501-a10a-71b3f8158848	2013-04-29	Warnings	Exact identifier spl set id: 560d75e7-8b91-4501-a10a-71b3f8158848

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.