MEDLINE RINSE- hydrogen peroxide mouthwash
Medline Industries, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

145 Hydrogen Peroxide Oral Rinse

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

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

Label 06 Label 08 Label 14

MEDLINE RINSE
hydrogen peroxide mouthwash

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-145-14	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019	01/01/2021
2	NDC:53329-145-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019	01/01/2021
3	NDC:53329-145-06	476 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019	01/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/01/2019	01/01/2021

Labeler - Medline Industries, LP (025460908)

Revised: 10/2021

Document Id: cf2f41b4-f6dc-1fe3-e053-2a95a90afe19

Set id: 9a259617-3fd4-5d99-e053-2a95a90a1f1b

Version: 3

Effective Time: 20211025

Medline Industries, LP