Search by Drug Name or NDC
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)
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 |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ec7a9240-6c66-4471-b8b6-776e08a14fbc Details
Warnings
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.
Manufacturing Information
INGREDIENTS AND APPEARANCE
MEDLINE PEROXI FRESH
MOUTHWASH
hydrogen peroxide mouthwash |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
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