PureLife APF

Manufacturer: PureLife Dental
Effective date: 2014-05-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:18:43

Label at a glance#

ProductPureLife APF

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

This is a prescription fluoride treatment foam used to help prevent dental decay.

Storage and handling

Store at controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.

Label contents#

Full prescribing information#

Active Ingredient:

SPL UNCLASSIFIED SECTION

1.23% Fluoride Ion.

Available from 1.81% Sodium Fluoride and Hydrofluoric Acid.

Purpose:

SPL UNCLASSIFIED SECTION

Fluoride Preventative Treatment Foam.

Indications and Usage:

INDICATIONS & USAGE SECTION

This is a prescription fluoride treatment foam used to help prevent dental decay.

Warnings:

WARNINGS SECTION

Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves, or other sources of heat. Do not puncture or incinerate container. Do not spray toward open flame. For Professional Use Only.

Instructions for Use

INSTRUCTIONS FOR USE SECTION

Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into fluoride tray (foam will expand slightly higher than the tray).
Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth for 1-4 minutes.
Use a saliva ejector during treatment to minimize ingestion of the product.
Remove tray(s) and have patient expectorate.
Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Distilled Water, Flavor, Hydrofluoric Acid, Isobutane Propane Propellant, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharin, Triethanolamine, Xylitol.

Other Information:

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59°-86°F (15°-30°C).

Protect from freezing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLFoamCherry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1484805	sodium fluoride 1.81 % Oral Foam	PSN	1
1484805	sodium fluoride 18.1 MG/ML Oral Foam	SCD	1
1484805	sodium fluoride 1.81 % (fluoride ion 1.23 % ) Oral Foam	SY	1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68987-021-12	PureLife APF	125 g in 1 BOTTLE, PUMP	AEROSOL, FOAM	125		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68987-021	PURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]	1	1 package rows	20140516_47ca5997-13e9-478a-b079-a4b6ee4dbf81.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
HYDROFLUORIC ACID	INACTIVE INGREDIENT	RGL5YE86CZ	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

PureLife APF
Sodium Fluoride
FLUORIDE ION
Water
HYDROFLUORIC ACID
PHOSPHORIC ACID
POLOXAMER 407
SODIUM BENZOATE
SODIUM LAURETH-3 SULFATE
SACCHARIN SODIUM
TROLAMINE
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68987-021	68987-021-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
Water	059QF0KO0R	IACT
HYDROFLUORIC ACID	RGL5YE86CZ	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM LAURETH-3 SULFATE	BPV390UAP0	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TROLAMINE	9O3K93S3TK	IACT
XYLITOL	VCQ006KQ1E	IACT

Source Document#

Source XML · Source PDF

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 3 · 151 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, EXTENDED RELEASE / ORAL	0.19 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAVENOUS		1294 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	CREAM / TOPICAL		13 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / INTRATYMPANIC		63 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / TOPICAL		28 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	LOTION / TOPICAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAMUSCULAR		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / TOPICAL	0.23 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	PASTE, DENTIFRICE / DENTAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM LAURETH-3 SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CAPSULE / ORAL	3.5 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 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
5198f457-335d-4559-9bad-366c3c2923f5			47ca5997-13e9-478a-b079-a4b6ee4dbf81	2014-05-14	Warnings	Exact identifier spl id: 5198f457-335d-4559-9bad-366c3c2923f5 spl set id: 47ca5997-13e9-478a-b079-a4b6ee4dbf81

Reported adverse events (FAERS/openFDA)#

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