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NDC 53329-0086-95 Medline Peroxi Fresh 15 mg/mL Details

Medline Peroxi Fresh 15 mg/mL

Medline Peroxi Fresh is a DENTAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries, LP. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	53329-0086
Product ID	53329-086_da305d7c-8182-78e2-e053-2995a90a011d
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	Medline Peroxi Fresh
Proprietary Name Suffix	Mouthwash
Non-Proprietary Name	Hydrogen Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	DENTAL
Active Ingredient Strength	15
Active Ingredient Units	mg/mL
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Medline Industries, LP
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 53329-0086-95 (53329008695)

Pricing Information	N/A
NDC Package Code	53329-086-95
Billing NDC	53329008695
Package	7 mL in 1 PACKET (53329-086-95)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec7a9240-6c66-4471-b8b6-776e08a14fbc Details

Active ingredient

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

Use

aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

Do not use this product

for more than 7 days unless directed by a dentist or physician.

When using this product

do not swallow

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

If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.

Directions

Adults and Children 2 Years of Age or Over: Swish around in mouth over affected area for 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 a doctor.

Other information

avoid excessive heat and protect from freezing

Inactive ingredients

flavor, sodium lauryl sulfate, sodium saccharin, water

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS096065HP

V1 RB22ANO

Package Label

INGREDIENTS AND APPEARANCE

MEDLINE PEROXI FRESH MOUTHWASH

hydrogen peroxide mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-086
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-086-13	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2007	12/31/2017
2	NDC:53329-086-66	10 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2007	07/31/2021
3	NDC:53329-086-14	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/08/2017
4	NDC:53329-086-95	7 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/01/2007

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 3/2022

Document Id: da305d7c-8182-78e2-e053-2995a90a011d

Set id: ec7a9240-6c66-4471-b8b6-776e08a14fbc

Version: 10

Effective Time: 20220314