PERIO DAILY DEFENSE- hydrogen peroxide gel 
Den-Mat Holdings, LLC

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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Active ingredient

Hydrogen Peroxide 1.7% w/w

Purpose

Wound Cleaner

Uses

For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Daily Defense may be used for lessening the presence of plaque, a known factor in development of gingivitis.

Warnings

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

Stop use and ask your dentist or physician if:

Keep out of reach of children section

Children under 12 years of age should be supervised when using this product.

Directions

For children under 2 years of age, consult a dentist or physician.

For adults and children 2 years of age or older:

  1. Apply several drops of gel directly onto the affected area in the mouth.
  2. Leave the material on the affected area for at least 60 seconds, then spit.
  3. Use up to 4 times daily after meals and or at bedtime, or as directed by a dentist or physician.

Other Information

Store at controlled room temperature, 20-25º C (68-77º F) and away from direct sunlight. For your protection, do not use if tamper seal on box is broken or missing.

Inactive Ingredients

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

Labeling

Carton

PERIO DAILY DEFENSE 
hydrogen peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE17 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SORBITOL (UNII: 506T60A25R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
ALCOHOL (UNII: 3K9958V90M)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT ((Clean Mint)) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59883-017-031 g in 1 TUBE; Type 0: Not a Combination Product08/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/31/2022
Labeler - Den-Mat Holdings, LLC (809857704)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies, Inc.148312838manufacture(59883-017) , label(59883-017) , pack(59883-017)

Revised: 8/2022
Document Id: e77b0956-0c5c-26d7-e053-2a95a90add9b
Set id: e77b0956-0c5b-26d7-e053-2a95a90add9b
Version: 1
Effective Time: 20220830
 
Den-Mat Holdings, LLC