PERIO ARMOR-X- 1.7% hydrogen peroxide gel

Perio Armor-X by

Drug Labeling and Warnings

Perio Armor-X by is a Otc medication manufactured, distributed, or labeled by Gingi-Pak a Division of the Belport, Jeff Nichols. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Hydrogen Peroxide 1.7% (w/w)

Purpose

Wound Cleanser

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.

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.

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.

Inactive Ingredients

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

Question or Comments?

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

Warnings

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

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

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PERIO ARMOR-X 
1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10129-039
Route of Administration	PERIODONTAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
XYLITOL (UNII: VCQ006KQ1E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SORBITOL (UNII: 506T60A25R)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10129-039-03	1 in 1 BOX	08/15/2022
1		86 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/15/2022

PERIO ARMOR-X 
1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10129-038
Route of Administration	PERIODONTAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ALCOHOL (UNII: 3K9958V90M)
XYLITOL (UNII: VCQ006KQ1E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10129-038-03	1 in 1 BOX	08/15/2022
1		86 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/15/2022

PERIO ARMOR-X 
1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10129-042
Route of Administration	PERIODONTAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
XYLITOL (UNII: VCQ006KQ1E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SORBITOL (UNII: 506T60A25R)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10129-042-03	1 in 1 BOX	08/15/2022
1		86 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/15/2022

Labeler - Gingi-Pak a Division of the Belport (008480121)

Registrant - Jeff Nichols (008480121)

Establishment
Name	Address	ID/FEI	Business Operations
Gingi-Pak a Division of the Belport		008480121	manufacture(10129-038, 10129-039, 10129-042)