periorestore

periorestore
SPL v3
SPL
SPL Set ID 97a07c36-1af8-a636-e053-2a95a90ad6db
Route
dental
Published
Effective Date 2022-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrogen peroxide (17 mg)
Inactive Ingredients
sorbitol menthol methyl salicylate phosphoric acid potassium sorbate water polysorbate 20 saccharin poloxamer 407 alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-07-15

Purpose

Wound Cleanser

Description

Hydrogen Peroxide 1.7% w/w


Medication Information

Warnings

Do not use Perio Restore Gel for more than 7 days unless directed by your dentist or physician. Stop use and ask your dentist or physician if:

  • Symptoms of wounds or inflammation do not improve within 7 days.
  • Irritation, pain or redness persists or worsens
  • Swelling, rash or fever develops
Purpose

Wound Cleanser

Directions

For children under 2 years of age, consult dentist or physician.

For adults and children 2 years of age and older:

1. Apply several drops of gel directly onto the affected area in the mouth.

2. Leave the material on the affected area for at least 60 seconds, then spit.

3. Use up to 4 times daily after meals and or a bedtime, or as directed by a dentist or physician.

Other Information

Store at a controlled room temperature, 25-25° C (68-77° F) and away from direct sunlight.

For your protection, do not use if tamper seal on box is broken or missing.

Inactive Ingredients

Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water.

Description

Hydrogen Peroxide 1.7% w/w

Principal Display Panel

PerioRestore™

Oral Cleaning Gel

Clean Mint

1.7% Hydrogen Peroxide

Net Wt. 3 oz. (85 g)

Active Ingredients

Hydrogen Peroxide

1.7% w/w

Indications & Uses

For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Restore may be used for lessening the presence of plaque, a known factor in development of gingivitis.

Keep Out of Reach of Children.

Children under 12 years of age should be supervised when using this product.


Structured Label Content

Warnings

Do not use Perio Restore Gel for more than 7 days unless directed by your dentist or physician. Stop use and ask your dentist or physician if:

  • Symptoms of wounds or inflammation do not improve within 7 days.
  • Irritation, pain or redness persists or worsens
  • Swelling, rash or fever develops
Purpose

Wound Cleanser

Directions

For children under 2 years of age, consult dentist or physician.

For adults and children 2 years of age and older:

1. Apply several drops of gel directly onto the affected area in the mouth.

2. Leave the material on the affected area for at least 60 seconds, then spit.

3. Use up to 4 times daily after meals and or a bedtime, or as directed by a dentist or physician.

Other Information

Store at a controlled room temperature, 25-25° C (68-77° F) and away from direct sunlight.

For your protection, do not use if tamper seal on box is broken or missing.

Inactive Ingredients

Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water.

Principal Display Panel

PerioRestore™

Oral Cleaning Gel

Clean Mint

1.7% Hydrogen Peroxide

Net Wt. 3 oz. (85 g)

Active Ingredients

Hydrogen Peroxide

1.7% w/w

Indications & Uses

For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Restore may be used for lessening the presence of plaque, a known factor in development of gingivitis.

Keep Out of Reach of Children. (Keep out of reach of children.)

Children under 12 years of age should be supervised when using this product.


Advanced Ingredient Data


Raw Label Data

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