Label: PERIO ARMOR-X- 1.7% hydrogen peroxide gel

  • NDC Code(s): 10129-038-03, 10129-039-03, 10129-042-03
  • Packager: Gingi-Pak a Division of the Belport
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 30, 2022

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  • 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

    Perio Armor-X Strawberry

    Perio Armor-X CottonCandy

    Perio Armor-X Mint

  • INGREDIENTS AND APPEARANCE
    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)
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