Perio Armor

Perio Armor
SPL v3
SPL
SPL Set ID e64fc96f-7ef8-aece-e053-2a95a90a898a
Routes
DENTAL PERIODONTAL
Published
Effective Date 2022-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (17 g)
Inactive Ingredients
Edta Carbomer 940 Water Saccharin Sodium Glycerin 2-amino-2-methyl-1-propanol Oleate Sodium Benzoate Spearmint

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-10-25 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.

Stop Use

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

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.

Do Not Use

Do not use Perio Armor for more than 7 days unless directed by your 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

Principle Display

Indication 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.

Inactive Ingredients (mint Flavor)

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

Inactive Ingredients (strawberry and Bubblegum)

Ethyl Alcohol, Phosphoric Acide, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water, Natural and Artificial Flavors


Structured Label Content

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Wound Cleanser

Stop Use (Stop use)

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

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.

Do Not Use (Do not use)

Do not use Perio Armor for more than 7 days unless directed by your 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

Principle Display

Indication 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.

Inactive Ingredients (mint Flavor) (Inactive Ingredients (mint flavor))

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

Inactive Ingredients (strawberry and Bubblegum) (Inactive Ingredients (Strawberry and Bubblegum))

Ethyl Alcohol, Phosphoric Acide, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Sodium Saccharin, Sorbitol, Water, Natural and Artificial Flavors


Advanced Ingredient Data


Raw Label Data

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