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NDC 10129-0019-03 Perio Armor 17 g/100mL Details

Perio Armor 17 g/100mL

Perio Armor is a DENTAL; PERIODONTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Gingi-Pak a Division of the Belport. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	10129-0019
Product ID	10129-019_ec1cc8d2-9953-2f21-e053-2995a90acd6e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Perio Armor
Proprietary Name Suffix	n/a
Non-Proprietary Name	1.7% Hydrogen Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	DENTAL; PERIODONTAL
Active Ingredient Strength	17
Active Ingredient Units	g/100mL
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Gingi-Pak a Division of the Belport
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10129-0019-03 (10129001903)

Pricing Information	N/A
NDC Package Code	10129-019-03
Billing NDC	10129001903
Package	1 TUBE in 1 BOX (10129-019-03) / 88.7 mL in 1 TUBE
Marketing Start Date	2022-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e64fc96f-7ef8-aece-e053-2a95a90a898a Details

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

Principal Display

INGREDIENTS AND APPEARANCE

PERIO ARMOR

1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-018
Route of Administration	DENTAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	17 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-018-03	1 in 1 BOX	08/15/2022
1		88.7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/2022

PERIO ARMOR

1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-019
Route of Administration	DENTAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	17 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-019-03	1 in 1 BOX	08/15/2022
1		88.7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/2022

PERIO ARMOR

1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-020
Route of Administration	DENTAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	17 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-020-03	1 in 1 BOX	08/15/2022	10/25/2022
1		88.7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/2022	10/25/2022

PERIO ARMOR

1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-032
Route of Administration	DENTAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	17 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-032-03	1 in 1 BOX	10/25/2022
1		88.7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	10/25/2022

Labeler - Gingi-Pak a Division of the Belport (008480121)

Registrant - Jeff Nichols (008480121)

Name	Address	ID/FEI	Business Operations
Establishment
Gingi-Pak a Division of the Belport		008480121	manufacture(10129-018, 10129-019, 10129-020, 10129-032)

Revised: 10/2022

Document Id: ec1cc8d2-9953-2f21-e053-2995a90acd6e

Set id: e64fc96f-7ef8-aece-e053-2a95a90a898a

Version: 2

Effective Time: 20221028

Search by Drug Name or NDC

NDC 10129-0019-03 Perio Armor 17 g/100mL Details

Perio Armor 17 g/100mL

Product Information

Package

Package Images

NDC 10129-0019-03 (10129001903)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e64fc96f-7ef8-aece-e053-2a95a90a898a Details

Active Ingredient

Purpose

Indication and Uses

Directions

Other Information

Inactive Ingredients (mint flavor)

Question or comments?

Warning

Do not use

Stop use

Inactive Ingredients (Strawberry and Bubblegum)

Principle Display

Principle Display

Principle Display

Principal Display

INGREDIENTS AND APPEARANCE

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