NDC 39892-0700 Medichoice Of Hydrogen Peroxide 3 10 Volume

Hydrogen Peroxide

NDC Product Code 39892-0700

NDC Code: 39892-0700

Proprietary Name: Medichoice Of Hydrogen Peroxide 3 10 Volume Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrogen Peroxide Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 39892 - Owens & Minor Distribution, Inc.
    • 39892-0700 - Medichoice Of Hydrogen Peroxide 3 10 Volume

NDC 39892-0700-1

Package Description: 118 mL in 1 BOTTLE

NDC 39892-0700-2

Package Description: 237 mL in 1 BOTTLE

NDC 39892-0700-3

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Medichoice Of Hydrogen Peroxide 3 10 Volume with NDC 39892-0700 is a a human over the counter drug product labeled by Owens & Minor Distribution, Inc.. The generic name of Medichoice Of Hydrogen Peroxide 3 10 Volume is hydrogen peroxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Owens & Minor Distribution, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Medichoice Of Hydrogen Peroxide 3 10 Volume Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROGEN PEROXIDE 30 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Owens & Minor Distribution, Inc.
Labeler Code: 39892
FDA Application Number: part333A Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-20-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Medichoice Of Hydrogen Peroxide 3 10 Volume Product Label Images

Medichoice Of Hydrogen Peroxide 3 10 Volume Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Purpose

First aid antiseptic/Oral debriding agent

Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes and burns


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

Warnings

For external use only

Do Not Use

• in the eyes or apply over large areas of the body • longer than 1 week

Ask A Doctor Before Use If You Have

Deep or puncture wounds, animal bites or serious burns

Stop Use And Ask A Doctor If

• the condition persists or gets worse


• 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

First aid antiseptic:


• clean the affected area


• apply a small amount of product on the area 1 to 3 times daily


• may be covered with a sterile bandage


• if bandaged, let dry first 
Oral debriding agent (oral rinse): adults and children 2 years of age and over:

• mix with an equal amount of water


• swish around in the mouth over the 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 doctor

Other Information

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

Purified water

* Please review the disclaimer below.

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