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NDC 59883-0202-64 DenMat Hydrogen Peroxide Oral Rinse 15 mg/mL Details
DenMat Hydrogen Peroxide Oral Rinse 15 mg/mL
DenMat Hydrogen Peroxide Oral Rinse is a TOPICAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by Den-Mat Holdings, LLC. The primary component is HYDROGEN PEROXIDE.
Product Information
NDC | 59883-0202 |
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Product ID | 59883-202_de0f54b0-a826-a090-e053-2995a90aeb32 |
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 | DenMat Hydrogen Peroxide Oral Rinse |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Hydrogen Peroxide Oral Rinse |
Product Type | HUMAN OTC DRUG |
Dosage Form | RINSE |
Route | TOPICAL |
Active Ingredient Strength | 15 |
Active Ingredient Units | mg/mL |
Substance Name | HYDROGEN PEROXIDE |
Labeler Name | Den-Mat Holdings, 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 59883-0202-64 (59883020264)
NDC Package Code | 59883-202-64 |
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Billing NDC | 59883020264 |
Package | 1893 mL in 1 BOTTLE, DISPENSING (59883-202-64) |
Marketing Start Date | 2022-05-02 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL de0f54b0-a825-a090-e053-2995a90aeb32 Details
SPL UNCLASSIFIED SECTION
For temporary use to reduce bacteria in the mouth to cleanse or facilitate healing of minor mouth irritations, such as canker sores, minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury or other irritations of the mouth and gums.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
Adults and children 6 years of age and older: fill dose cup to 10 mL (two
teaspoons) and rinse around in the mouth over affected area for
at least 1 minute, then spit out
Use up to 4 times daily after meals and at bedtime or as directed by
a dentist or physician
Children under 12 years of age should be supervised in the use of
the product
Children under 6 years of age: consult a dentist or physician
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
DENMAT HYDROGEN PEROXIDE ORAL RINSE
hydrogen peroxide oral rinse rinse |
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Labeler - Den-Mat Holdings, LLC (809857704) |
Registrant - Den-Mat Holdings, LLC (809857704) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Den-Mat Holdings, LLC | 809857704 | manufacture(59883-202) , label(59883-202) , pack(59883-202) |