peroxy shield - mint

peroxy shield - mint
SPL v5
SPL
SPL Set ID a72e433b-1b7d-4a0c-e053-2995a90a30c4
Route
oral
Published
Effective Date 2020-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrogen peroxide (1.5 mL)
Inactive Ingredients
methyl salicylate sucralose poloxamer 407 polysorbate 20 propanediol water sorbitol solution 70% fd&c blue no. 1 saccharin sodium menthol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-06-03

Purpose

Oral debriding agent/oral wound cleaner

Description

Hydrogen peroxide 1.5% (w/w)


Medication Information

Warnings

Do not use this product for more than 7 days unless directed by your dentist or physician.

Uses
  • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
Purpose

Oral debriding agent/oral wound cleaner

Directions
  • For adults and children under 2 years of age or older: rinse 10mL around in the mouth over the affected area 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.
Other Information
  • Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight.
  • For your protection, do not use if tamper evident seal under the cap is damaged or missing.
Inactive Ingredients

FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water

Description

Hydrogen peroxide 1.5% (w/w)

Principal Display Panel

ALCOHOL FREE

PEROXY SHIELD®

1.5% HYDROGEN PEROXIDE

MOUTH SORE RINSE

HELPS PROMOTE

A CLEANER MOUTH & HEALING OF

  • ORAL SORES
  • IRRITATIONS
  • MOUTH BURNS

MINT FLAVOR

REF. 035-0101-002

63.0 FL. OZ. (1863 mL)

Purpose(s)

Oral debriding agent/oral wound cleaner

Active Ingredient

Hydrogen peroxide 1.5% (w/w)

Questions Or Comments?

Call 1-800-835-0885


Structured Label Content

Warnings

Do not use this product for more than 7 days unless directed by your dentist or physician.

Uses
  • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
Directions
  • For adults and children under 2 years of age or older: rinse 10mL around in the mouth over the affected area 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.
Other Information (Other information)
  • Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight.
  • For your protection, do not use if tamper evident seal under the cap is damaged or missing.
Inactive Ingredients (Inactive ingredients)

FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water

Principal Display Panel

ALCOHOL FREE

PEROXY SHIELD®

1.5% HYDROGEN PEROXIDE

MOUTH SORE RINSE

HELPS PROMOTE

A CLEANER MOUTH & HEALING OF

  • ORAL SORES
  • IRRITATIONS
  • MOUTH BURNS

MINT FLAVOR

REF. 035-0101-002

63.0 FL. OZ. (1863 mL)

Purpose(s)

Oral debriding agent/oral wound cleaner

Active Ingredient (Active ingredient)

Hydrogen peroxide 1.5% (w/w)

Questions Or Comments? (Questions or comments?)

Call 1-800-835-0885


Advanced Ingredient Data


Raw Label Data

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