PCxx

Manufacturer: Ross Healthcare Inc.
Effective date: 2012-12-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:16:22

Label at a glance#

ProductPCxx

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Dosage and administration

DIRECTIONS FOR USE: 1. Use after prophylaxis. 2. Shake bottle vigorously for 3-4 seconds. 3. For adults and children age 6 and older. 4. Invert applicator. 5. Place nozzle to applicator tray and dispense. 6. Allow foam to expand in tray. 7. Have patient bite down for up to 4 minutes. 8. Remove trays and have patient expectorate excess. 9. Do not eat or drink for 30 minutes after use.

Contacts and useful links#

PhoneLabel contact1-800-663-8303

Websitewww.rosshealthcare.org

www.rosshealthcare.org

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT: 2.0% Sodium Fluoride

Use

OTC - PURPOSE SECTION

Use: Professional Use Anticavity Treatment

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Use

INDICATIONS & USAGE SECTION

Use: Professional Use Anticavity Treatment

Cautions and Warnings

WARNINGS SECTION

Cautions and Warnings:

Keep out of reach of children. Rx only. Do not puncture or incinerate. Do not store above 50 degrees C. Do not use in the presence of open flame. Contents under pressure. Do not place near any heat source.

Directions For Use

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS FOR USE:

1. Use after prophylaxis.

2. Shake bottle vigorously for 3-4 seconds.

3. For adults and children age 6 and older.

4. Invert applicator.

5. Place nozzle to applicator tray and dispense.

6. Allow foam to expand in tray.

7. Have patient bite down for up to 4 minutes.

8. Remove trays and have patient expectorate excess.

9. Do not eat or drink for 30 minutes after use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Glycerin, Xylitol, Sucralose, Poloxamer, Sodium Lauryl Sulphate, Xantham Gum, Flavour, Potassium Sorbate.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCxx

Professional Care Products

NEUTRAL FOAM

TOPICAL FLUORIDE FOAM

2.0% Sodium Fluoride

NO FLAVOR

Net Contents: 125 g

NPN# 800004635

NDC# 062007-105-07

Ross Healthcare Inc. 1-800-663-8303 / www.rosshealthcare.org

Made in Canada

LOT 27121A6

EXPIRY 12-2014

Ross Healthcare PCxx Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1363558	PCxx Neutral Foam 2 % Oral Foam	PSN	1
688393	sodium fluoride 2 % Oral Foam	PSN	1
1363558	sodium fluoride 20 MG/ML Oral Foam [PCxx Neutral Foam]	SBD	1
688393	sodium fluoride 20 MG/ML Oral Foam	SCD	1
1363558	PCxx Neutral Foam 2 % Oral Foam	SY	1
1363558	PCxx Neutral Foam 20 MG/ML Oral Foam	SY	1
688393	sodium fluoride 2 % Oral Foam	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62007-105-07	2020-01-31	C162847	48780-1	9d75b9d0-bf7a-f424-e053-dadaa90a57ce	9f9f36e7-ec66-473d-af17-09d4b492ded5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62007-105-07	PCxx	125 g in 1 CANISTER	AEROSOL, FOAM	125		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62007-105	PCXX (SODIUM FLUORIDE) AEROSOL, FOAM [ROSS HEALTHCARE INC.]	1	Legacy NDC, 1 package rows	20121218_9f9f36e7-ec66-473d-af17-09d4b492ded5.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
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

PCxx
SODIUM FLUORIDE
FLUORIDE ION
GLYCERIN
XYLITOL
SUCRALOSE
POLOXAMER 407
SODIUM LAURYL SULFATE
XANTHAN GUM
POTASSIUM SORBATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62007-105	62007-105-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
XYLITOL	VCQ006KQ1E	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
XANTHAN GUM	TTV12P4NEE	IACT
POTASSIUM SORBATE	1VPU26JZZ4	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 4 · 214 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / OPHTHALMIC		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / INTRATYMPANIC		63 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 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
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 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
db6a3378-8e87-43ad-8c82-8a0a985e3b5e			9f9f36e7-ec66-473d-af17-09d4b492ded5	2012-12-17	Warnings	Exact identifier spl id: db6a3378-8e87-43ad-8c82-8a0a985e3b5e spl set id: 9f9f36e7-ec66-473d-af17-09d4b492ded5

Reported adverse events (FAERS/openFDA)#

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