perox-a-mint® solution

perox-a-mint® solution
SPL v14
SPL
SPL Set ID 50823ff5-ad08-4449-bc4a-9a8ae25ec0d5
Route
buccal
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrogen peroxide (15 mg)
Inactive Ingredients
water phosphoric acid polysorbate 80 saccharin sodium fd&c blue no. 1 fd&c yellow no. 6

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1998-05-21 Until 2018-08-20

Purpose

Oral Debriding Agent

Description

Hydrogen Peroxide 1.5%


Medication Information

Purpose

Oral Debriding Agent

Directions
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
  • Children under 12 years of age:  supervise use.
  • Children under 3 years of age:  consult a dentist or doctor.
Inactive Ingredients

Blue 1 (CI42090), menthol flavor, phosphoric acid, polysorbate 80, sodium saccharin, Water, Yellow 6 (CI15985)

Description

Hydrogen Peroxide 1.5%

Use

Aids in the removal of secretions associated with sore mouth

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists of worsens.
Section 50570-1

Do not use:

  • For more than 7 days unless told to do so by a doctor.
  • Avoid swallowing.
Section 53413-1

Questions?Call toll free 800-323-2220

Active Ingredient

Hydrogen Peroxide 1.5%

Perox A Mint Solution


Structured Label Content

Purpose

Oral Debriding Agent

Directions
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
  • Children under 12 years of age:  supervise use.
  • Children under 3 years of age:  consult a dentist or doctor.
Inactive Ingredients

Blue 1 (CI42090), menthol flavor, phosphoric acid, polysorbate 80, sodium saccharin, Water, Yellow 6 (CI15985)

Use

Aids in the removal of secretions associated with sore mouth

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists of worsens.
Section 50570-1 (50570-1)

Do not use:

  • For more than 7 days unless told to do so by a doctor.
  • Avoid swallowing.
Section 53413-1 (53413-1)

Questions?Call toll free 800-323-2220

Active Ingredient (Active ingredient)

Hydrogen Peroxide 1.5%

Perox A Mint Solution (Perox-A-Mint Solution)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)