086 Medline Peroxi Fresh

086 Medline Peroxi Fresh
SPL v11
SPL
SPL Set ID ec7a9240-6c66-4471-b8b6-776e08a14fbc
Route
DENTAL
Published
Effective Date 2018-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (15 mg)
Inactive Ingredients
Sodium Lauryl Sulfate Saccharin Sodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2007-01-01 Until 2021-07-31

Description

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent


Medication Information

Purpose

Oral Debriding Agent

Description

Hydrogen Peroxide 1.5%

Use
  • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Warnings



Directions
  • Adults and Children 2 Years of Age or Over: Swish around in mouth over affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a 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.
Package Label

Active Ingredient

Hydrogen Peroxide 1.5%

Other Information
  • avoid excessive heat and protect from freezing
Inactive Ingredients

flavor, sodium lauryl sulfate, sodium saccharin, water

Do Not Use This Product
  • for more than 7 days unless directed by a dentist or physician.

When Using This Product
  • do not swallow

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS096065HP

V1 RB22ANO

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 more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.


Structured Label Content

Use
  • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Purpose

Oral Debriding Agent

Warnings



Directions
  • Adults and Children 2 Years of Age or Over: Swish around in mouth over affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a 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.
Package Label

Active Ingredient (Active ingredient)

Hydrogen Peroxide 1.5%

Other Information (Other information)
  • avoid excessive heat and protect from freezing
Inactive Ingredients (Inactive ingredients)

flavor, sodium lauryl sulfate, sodium saccharin, water

Do Not Use This Product (Do not use this product)
  • for more than 7 days unless directed by a dentist or physician.

When Using This Product (When using this product)
  • do not swallow

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS096065HP

V1 RB22ANO

Stop Use and Ask A Doctor If (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 (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.


Advanced Ingredient Data


Raw Label Data

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