IIMED Hydrogen Peroxide Oral Rinse

Medline Peroxi Fresh Mouthwash by

Drug Labeling and Warnings

Medline Peroxi Fresh Mouthwash by is a Otc medication manufactured, distributed, or labeled by IIMED MEDICAL MEXICANA S DE RL DE CV, Team Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDLINE PEROXI FRESH MOUTHWASH- hydrogen peroxide mouthwash mouthwash 
IIMED MEDICAL MEXICANA S DE RL DE CV

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IIMED Hydrogen Peroxide Oral Rinse

Active ingredient

Hydrogen peroxide 1.5%

Purpose

Oral debriding agent

Use

Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

Warnings

Do not use

for more than 7 days unless directed by a dentist or physician

When using this product

Do not swallow

Stop use and ask a doctor if

-sore mouth symptoms do not improve in 7 days

-irritation, pain or redness persists or worsens

-swelling, rash or fever develops

Keep out of reach of children if

If more than used for rinsing is accidentally swallowed, get medical hep or contact Poison Control Center right away

Directions

-Adults and children 2 years of age or over: swish around in mouth over affected afrea for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by dentist or doctor.

-Children under 12 years of age: Should be supervised in the use of this product.

-Children under 2 years of age: Consult a dentist or a doctor.

Other information

Avoid excessive heat and protect from freezing.

Inactive ingredients

flavor, sodium lauryl sulfate, sodium saccharin, water

Label

MEDLINE PEROXI FRESH MOUTHWASH 
hydrogen peroxide mouthwash mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83062-086(NDC: 53329-086)
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83062-086-95	7 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/06/2023

Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)

Registrant - Team Technologies (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
IIMED MEDICAL MEXICANA S DE RL DE CV		812894376	repack(83062-086) , relabel(83062-086)

Revised: 10/2023

Document Id: 0714d475-68d1-9eb7-e063-6294a90a1c12

34390-5

Set id: 0714d475-68d0-9eb7-e063-6294a90a1c12

Version: 1

Effective Time: 20231006