Prevention Oncology Mouth Rinse

Prevention Oncology Mouth Rinse
SPL v5
SPL
SPL Set ID 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (4.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Water Edetate Disodium Hydrogen Peroxide Menthol Peppermint Oil Poloxamer 407 Sodium Citrate Zinc Chloride Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-10

Description

Glycerin 4.5%

Purpose

Oral Demulcent


Medication Information

Purpose

Oral Demulcent

Description

Glycerin 4.5%

Uses

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

Section 42229-5

Formulated and Ditributed by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

PHS Brands

www.preventionhs.com

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product, do not swallow.

Section 50570-1

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

Section 51945-4

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

Section 53413-1

Questions Call 800-473-1205

Directions

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

keep product away from heat or direct sunlight

DO NOT USE IF SAFETY SEAL IS BROKEN

Active Ingredients

Glycerin 4.5%

Inactive Ingredients

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Formulated and Ditributed by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

PHS Brands

www.preventionhs.com

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product, do not swallow.

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions Call 800-473-1205

Purpose

Oral Demulcent

Directions

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 (Other information)

keep product away from heat or direct sunlight

DO NOT USE IF SAFETY SEAL IS BROKEN

Active Ingredients

Glycerin 4.5%

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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