Label: PERIO ARMOR- 1.7% hydrogen peroxide gel

  • NDC Code(s): 10129-018-03, 10129-019-03, 10129-020-03, 10129-032-03
  • 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 October 28, 2022

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  • Active Ingredient

    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 (mint flavor)

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

  • Question or comments?

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

  • Warning

    Do not use

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

    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

    Keep out of reach of children.

  • Inactive Ingredients (Strawberry and Bubblegum)

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

  • Principle Display

    Perio Armor Strawberry

  • Principle Display

    Perio Armor Cotton Candy

  • Principle Display

    Perio Armor Mint

  • Principal Display

    Perio Armor Bubblegum

  • INGREDIENTS AND APPEARANCE
    PERIO ARMOR 
    1.7% hydrogen peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-018
    Route of AdministrationDENTAL, PERIODONTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10129-018-031 in 1 BOX08/15/2022
    188.7 mL 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 
    1.7% hydrogen peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-019
    Route of AdministrationDENTAL, PERIODONTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10129-019-031 in 1 BOX08/15/2022
    188.7 mL 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 
    1.7% hydrogen peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-020
    Route of AdministrationDENTAL, PERIODONTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10129-020-031 in 1 BOX08/15/202210/25/2022
    188.7 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/15/202210/25/2022
    PERIO ARMOR 
    1.7% hydrogen peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-032
    Route of AdministrationDENTAL, PERIODONTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10129-032-031 in 1 BOX10/25/2022
    188.7 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/25/2022
    Labeler - Gingi-Pak a Division of the Belport (008480121)
    Registrant - Jeff Nichols (008480121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gingi-Pak a Division of the Belport008480121manufacture(10129-018, 10129-019, 10129-020, 10129-032)
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