PCXX ONE MINTE GEL CREME DE MENTHE

Manufacturer: Ross Healthcare Inc.
Effective date: 2014-05-21
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:18:47

Label at a glance#

ProductPCXX ONE MINTE GEL CREME DE MENTHE

Active ingredientSODIUM FLUORIDE

Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCXX ONE MINUTE MT FRONT PANEL

WARNINGS AND PRECAUTIONS SECTION

PCXX ONE MINUTE MT SECONDARY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62007-006-16	2020-01-31	C162847	48780-1	9d75b9cf-f7b5-f424-e053-dadaa90a57ce	47d28652-9ec2-4ca9-b6c7-8007b3e0963b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62007-006-16	PCXX ONE MINTE GEL CREME DE MENTHE	1 mg in 1 BOTTLE, PLASTIC	GEL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62007-006	PCXX ONE MINTE GEL CREME DE MENTHE (FLUORIDE TREATMENT) GEL [ROSS HEALTHCARE INC.]	1	Legacy NDC, 1 package rows	20140530_47d28652-9ec2-4ca9-b6c7-8007b3e0963b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

PCXX ONE MINTE GEL CREME DE MENTHE
FLUORIDE TREATMENT
SODIUM FLUORIDE
FLUORIDE ION
FD&C GREEN NO. 3

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62007-006	62007-006-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
FD&C GREEN NO. 3	3P3ONR6O1S	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 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SUPPOSITORY / RECTAL	0.02 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	ELIXIR / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, EXTENDED RELEASE / ORAL	0.16 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	GEL / DENTAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SHAMPOO / TOPICAL	0.09 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SYRUP / ORAL	3.75 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, LIQUID FILLED / ORAL	0.03 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET / ORAL		240 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 15 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
b2a2cf43-894c-4684-8389-b643e7e6cc84			47d28652-9ec2-4ca9-b6c7-8007b3e0963b	2014-05-21	Warnings	Exact identifier spl id: b2a2cf43-894c-4684-8389-b643e7e6cc84 spl set id: 47d28652-9ec2-4ca9-b6c7-8007b3e0963b

Reported adverse events (FAERS/openFDA)#

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