Perio Daily Defense by Den-Mat Holdings, LLC / Dental Technologies, Inc.

Perio Daily Defense by

Drug Labeling and Warnings

Perio Daily Defense by is a Otc medication manufactured, distributed, or labeled by Den-Mat Holdings, LLC, Dental Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

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:

• Symptoms of wounds or inflammation do not improve within 7 days.
• Irritation, pain or redness persists or worsens.
• Swelling, rash or fever develops.

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

PERIO DAILY DEFENSE 
hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	17 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT ((Clean Mint))	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-017-03	1 g in 1 TUBE; Type 0: Not a Combination Product	08/31/2022	02/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	08/31/2022	02/28/2023

Labeler - Den-Mat Holdings, LLC (809857704)

Establishment
Name	Address	ID/FEI	Business Operations
Dental Technologies, Inc.		148312838	manufacture(59883-017) , label(59883-017) , pack(59883-017)

Revised: 10/2024

Document Id: 24c5ad3e-bfa6-5768-e063-6394a90a367f

34390-5

Set id: e77b0956-0c5b-26d7-e053-2a95a90add9b

Version: 2

Effective Time: 20241018