Perio Max Plus

Perio Max Plus
SPL v2
SPL
SPL Set ID e7a27f6e-b4fa-0f8d-e053-2995a90a0975
Routes
DENTAL PERIODONTAL
Published
Effective Date 2022-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (1.7 g)
Inactive Ingredients
Alcohol Phosphoric Acid Poloxamer 407 Polysorbate 20 Methyl Salicylate Menthol Sorbitol Water Potassium Sorbate Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Completed Since 2022-08-15 Until 2022-10-25

Description

Hydrogen Peroxide 1.7% (w/w)

Purpose

Wound Cleanser


Medication Information

Purpose

Wound Cleanser

Description

Hydrogen Peroxide 1.7% (w/w)

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and consult your dentist or physician if: • Symptoms do not improve within 7 days • Irritation, pain, or redness persists or worsens • Swelling, rash, or fever develops

Section 50570-1

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

Directions

For children under 2 years of age, consult a dentist or physician before use. For adults and children 2 years of age or older: 1. Remove cap and cut the tip of the tube at the narrow end. 2. Apply several drops of the gel directly onto the affected area in the mouth. 3. Leave the gel on the affected area for at least 60 seconds, then spit. 4. Use up to 4 times daily after meals, at bedtime, or as directed by a dentist or physician.

Active Ingredient

Hydrogen Peroxide 1.7% (w/w)

Other Information

Store at room temperature between 20-25° C (68-77° F) and away from direct sunlight. Do not use if the tube has been damaged or tampered in any way

Principal Display

Principla Display

Inactive Ingredients

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

Indications and Uses

For temporary use in cleansing minor oral wounds and treatment of inflammation resulting from dental procedures or other irritations of the mouth and gums. Perio Armor may be used for decreasing the presence of plaque, a known factor in the development of gingivitis and tooth decay.

Question Or Comments?

(800)437-1514 or www.gingi-pak.com.


Structured Label Content

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and consult your dentist or physician if: • Symptoms do not improve within 7 days • Irritation, pain, or redness persists or worsens • Swelling, rash, or fever develops

Section 50570-1 (50570-1)

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

Purpose

Wound Cleanser

Directions

For children under 2 years of age, consult a dentist or physician before use. For adults and children 2 years of age or older: 1. Remove cap and cut the tip of the tube at the narrow end. 2. Apply several drops of the gel directly onto the affected area in the mouth. 3. Leave the gel on the affected area for at least 60 seconds, then spit. 4. Use up to 4 times daily after meals, at bedtime, or as directed by a dentist or physician.

Active Ingredient

Hydrogen Peroxide 1.7% (w/w)

Other Information

Store at room temperature between 20-25° C (68-77° F) and away from direct sunlight. Do not use if the tube has been damaged or tampered in any way

Principal Display

Principla Display

Inactive Ingredients

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

Indications and Uses

For temporary use in cleansing minor oral wounds and treatment of inflammation resulting from dental procedures or other irritations of the mouth and gums. Perio Armor may be used for decreasing the presence of plaque, a known factor in the development of gingivitis and tooth decay.

Question Or Comments? (Question or Comments?)

(800)437-1514 or www.gingi-pak.com.


Advanced Ingredient Data


Raw Label Data

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