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NDC 75908-0017-85 Periogel 17 mg/g Details

Periogel 17 mg/g

Periogel is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by QNT Anderson, LLC. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	75908-0017
Product ID	75908-017_4539ba00-922d-473d-8c61-2fa0c3ef5e97
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	Periogel
Proprietary Name Suffix	n/a
Non-Proprietary Name	hydrogen peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	DENTAL
Active Ingredient Strength	17
Active Ingredient Units	mg/g
Substance Name	HYDROGEN PEROXIDE
Labeler Name	QNT Anderson, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2023-12-31

Package

Package Images

NDC 75908-0017-85 (75908001785)

Pricing Information	N/A
NDC Package Code	75908-017-85
Billing NDC	75908001785
Package	1 TUBE in 1 CARTON (75908-017-85) / 85 g in 1 TUBE
Marketing Start Date	2011-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 30f97d9b-7551-499f-b3bb-5a658bd3a493 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrogen peroxide 1.7% (w/w)

Purpose

Oral Debriding Agent/Oral Wound Cleanser

Approved Uses

For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

Warnings

Do not use for more than 7 days unless directed by a dentist or doctor. Spit out excess medication.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens;
swelling, rash or fever develops.

Keep out of reach of children.

Directions for adults and children 2 years of age and older

Apply several drops to the affected area of the mouth.
Allow medication to remain in place at least 1 minute and then spit out.
Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
Children under 12 years of age should be supervised in the use of this product.
Children under 2 years of age:

Consult a dentist or doctor.

Other information

Store at controlled room temperature (68°-77°F) in a cool, dry place away from direct sunlight.

Inactive ingredients

Inactive ingredients: ethyl alcohol (5% w/w), menthol, methyl salicylate, phosphoric acid, poloxamer 407, polysorbate 20, potassium sorbate, sodium saccharin, sorbitol, water.

Questions or comments?

Call toll free 1-877-907-3746 from 9am - 5pm CST/CDT Monday-Friday.

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Periogel®

Oral Debriding Agent /

Oral Wound Cleanser

(Hydrogen Peroxide)

NET WT. 3 OZ. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

INGREDIENTS AND APPEARANCE

PERIOGEL

hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75908-017
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
alcohol (UNII: 3K9958V90M)	50 mg in 1 g
menthol, unspecified form (UNII: L7T10EIP3A)
methyl salicylate (UNII: LAV5U5022Y)
phosphoric acid (UNII: E4GA8884NN)
poloxamer 407 (UNII: TUF2IVW3M2)
polysorbate 20 (UNII: 7T1F30V5YH)
potassium sorbate (UNII: 1VPU26JZZ4)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitol (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75908-017-85	1 in 1 CARTON	04/01/2011
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:75908-017-28	1 in 1 CARTON	04/01/2011
2		28.3 g 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	04/01/2011

Labeler - QNT Anderson, LLC (962173030)

Name	Address	ID/FEI	Business Operations
Establishment
Unicep Packaging, Inc.		790263909	MANUFACTURE(75908-017)

Revised: 5/2022

Document Id: 4539ba00-922d-473d-8c61-2fa0c3ef5e97

Set id: 30f97d9b-7551-499f-b3bb-5a658bd3a493

Version: 4

Effective Time: 20220513