PERIO ARMOR-X- 1.7% hydrogen peroxide gel 
Gingi-Pak a Division of the Belport

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Perio Armor-X

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.

Perio Armor-X Strawberry

Perio Armor-X CottonCandy

Perio Armor-X Mint

PERIO ARMOR-X 
1.7% hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-039
Route of AdministrationPERIODONTAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-039-031 in 1 BOX08/15/2022
186 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/15/2022
PERIO ARMOR-X 
1.7% hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-038
Route of AdministrationPERIODONTAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-038-031 in 1 BOX08/15/2022
186 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/15/2022
PERIO ARMOR-X 
1.7% hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-042
Route of AdministrationPERIODONTAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-042-031 in 1 BOX08/15/2022
186 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/15/2022
Labeler - Gingi-Pak a Division of the Belport (008480121)
Registrant - Jeff Nichols (008480121)
Establishment
NameAddressID/FEIBusiness Operations
Gingi-Pak a Division of the Belport008480121manufacture(10129-038, 10129-039, 10129-042)

Revised: 8/2022
Document Id: e77bc6e7-de68-3e91-e053-2a95a90a96b2
Set id: e77bc6e7-de67-3e91-e053-2a95a90a96b2
Version: 1
Effective Time: 20220830
 
Gingi-Pak a Division of the Belport