MEDLINE RINSE- hydrogen peroxide mouthwash

Medline Rinse by

Drug Labeling and Warnings

Medline Rinse by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP, Vi-Jon, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen peroxide 1.5%

Purpose

Oral debriding agent/Oral wound cleanser

Uses

• aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
• for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums
• for temporary use to cleanse canker sores
• assists in the removal of foreign material from minor oral wounds

Warnings

Do not use

this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

When using this product

do not swallow

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: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
• children under 12 should be supervised in the use of the product
• children under 2 years of age: consult a dentist or doctor

Other information

store at controlled room temperature 68-77°F (20-25°C)

Inactive ingredients

blue 1, flavor, propylene glycol, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

SPL UNCLASSIFIED SECTION

www.medline.com Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. Made in the USA with U.S. and Foreign Components. 1-800-MEDLINE

Package Label

INGREDIENTS AND APPEARANCE

MEDLINE RINSE 
hydrogen peroxide mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-145
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 338 (UNII: F75JV2T505)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-145-14	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
2	NDC: 53329-145-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
3	NDC: 53329-145-06	476 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2019

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		790752542	manufacture(53329-145)