PREVENTION ONCOLOGY MOUTH RINSE- glycerin liquid

Prevention Oncology Mouth Rinse by

Drug Labeling and Warnings

Prevention Oncology Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Prevention Health Sciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Glycerin 4.5%

Purpose

Oral Demulcent

Uses

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

Warnings

DO NOT USE

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

WHEN USING

When using this product, do not swallow.

STOP USE

Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting

sore mouth symptoms do not improve in 7 days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older: gargle, swish one capful (10 ml) or more in mouth over affected area for one minute, then spit out. Use 3 to 4 times daily, before meals, at bedtime, and as needed.

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

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Manufactured by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

800-473-1205

www.preventionhs.com

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

PREVENTION ONCOLOGY MOUTH RINSE

Formulated for ONCOLOGY PATIENTS

• Soothes & Protects Oral Mucosa
• Provides Temporary Oral Pain Relief
• Relieves Dry Mouth Symptoms

Soothing Mint

NET. 16 FL OZ (1 PT) 473 ML

INGREDIENTS AND APPEARANCE

PREVENTION ONCOLOGY MOUTH RINSE 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69951-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	4.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
MENTHOL (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ZINC CHLORIDE (UNII: 86Q357L16B)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69951-001-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2015
2	NDC: 69951-001-03	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/02/2015

Labeler - Prevention Health Sciences, Inc. (968930540)

Establishment
Name	Address	ID/FEI	Business Operations
Prevention Health Sciences, Inc.		968930540	manufacture(69951-001)