Prevention Oncology Mouth Rinse

Manufacturer: Prevention Health Sciences, Inc.
Effective date: 2025-01-01
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:56:08

Label at a glance#

ProductPrevention Oncology Mouth Rinse

Active ingredientGLYCERIN

Label structure13 sections

Indications and uses

for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Dosage and administration

adults and children 2 years of age and older: gargle, swish around in the mouth over the affected area for at least one minute and then spit out. Use as needed or as directed by dentist or doctor. children under 12 years of age should be supervised in the use of product. children under 2 : consult with a dentist or doctor.

Storage and handling

keep product away from heat or direct sunlight DO NOT USE IF SAFETY SEAL IS BROKEN

Contacts and useful links#

PhoneLabel contact800-473-1205

Websitewww.preventionhs.com

www.preventionhs.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 4.5%

Purpose

OTC - PURPOSE SECTION

Oral Demulcent

Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

OTC - DO NOT USE SECTION

Do not use this product for more than 7 days unless directed by a dentist or physician

OTC - WHEN USING SECTION

When using this product, do not swallow.

OTC - STOP USE SECTION

Stop use and ask a doctor if

• sore throat is severe • lasts for more than 2 days • is accompanied or followed by fever, headache, rash, nausea or vomiting • sore mouth symptoms do not improve in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If 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: gargle, swish around in the mouth over the affected area for at least one minute and then spit out. Use as needed or as directed by dentist or doctor.

children under 12 years of age should be supervised in the use of product.

children under 2: consult with a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

keep product away from heat or direct sunlight

DO NOT USE IF SAFETY SEAL IS BROKEN

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, de-ionized water, disodium EDTA, hydrogen peroxide (0.15% concentration), menthol, peppermint oil, poloxamer 407, sodium citrate, xylitol, zinc chloride

OTC - QUESTIONS SECTION

Questions Call 800-473-1205

SPL UNCLASSIFIED SECTION

Formulated and Ditributed by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

PHS Brands

www.preventionhs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

PREVENTION MOUTH RINSE

Formulated for Oncology Patients

√ Soothes & Protects Oral Mucosa

√ Provides Temporary Oral Pain Relief

√ Hydrating Formula

Soothing Mint

NET. 16 FL OZ (1 PT) 473 ML

label

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GLYCERIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69951-001-03	2025-02-26	C162847	48780-1	2cef2736-78bb-d83d-e063-dadaa90ab31f	Prevention Oncology Mouth Rinse
69951-001-16	2025-02-26	C162847	48780-1	2cef2736-78bb-d83d-e063-dadaa90ab31f	Prevention Oncology Mouth Rinse
69951-001-03	2025-01-30	C162847	48780-1	2cef2736-78bb-d83d-e063-dadaa90ab31f	Prevention Oncology Mouth Rinse
69951-001-16	2025-01-30	C162847	48780-1	2cef2736-78bb-d83d-e063-dadaa90ab31f	Prevention Oncology Mouth Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69951-001-03	Prevention Oncology Mouth Rinse	95 mL in 1 BOTTLE, PLASTIC	LIQUID	95		5
69951-001-16	Prevention Oncology Mouth Rinse	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69951-001	PREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20250228_1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
HYDROGEN PEROXIDE	INACTIVE INGREDIENT	BBX060AN9V	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
ZINC CHLORIDE	INACTIVE INGREDIENT	86Q357L16B	1

Products#

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

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

Prevention Oncology Mouth Rinse
Glycerin
CITRIC ACID MONOHYDRATE
WATER
EDETATE DISODIUM
HYDROGEN PEROXIDE
MENTHOL
PEPPERMINT OIL
POLOXAMER 407
SODIUM CITRATE
ZINC CHLORIDE
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69951-001	69951-001-16, 69951-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
WATER	059QF0KO0R	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
MENTHOL	L7T10EIP3A	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
ZINC CHLORIDE	86Q357L16B	IACT
XYLITOL	VCQ006KQ1E	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 3 · 159 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route 69 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii+route 21 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii+route 27 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii+route 30 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii+route 69 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii+route 69 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route 21 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii+route 69 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii+route 27 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii+route 69 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii+route 27 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii+route 69 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii+route 69 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii+route 30 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii+route 30 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii+route 69 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii+route 21 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii+route 69 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii+route 69 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii+route 30 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii+route 69 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii+route 30 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii+route 69 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii+route 69 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii+route 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii+route 30 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii+route 69 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii+route 30 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii+route 69 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii+route 21 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii+route 21 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii+route 27 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii+route 21 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii+route 69 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii+route 69 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii+route 30 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
Prevention Oncology Mouth Rinse	GLYCERIN	Prevention Health Sciences, Inc.	1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c	2025-01-01	Warnings	Exact identifier ndc (package): 69951-001-03 ndc (package): 69951-001-16 ndc (product): 69951-001 ndc11 (package): 69951000116 ndc11 (package): 69951000103 spl id: 2ea9338d-fc20-b029-e063-6394a90a8a6e spl set id: 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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