NDC 78835-008 Prevent Hydrogen Peroxide 3 Percent

Hydrogen Peroxide

NDC Product Code 78835-008

NDC 78835-008-01

Package Description: 12 BOTTLE in 1 BOX > 500 mL in 1 BOTTLE

NDC Product Information

Prevent Hydrogen Peroxide 3 Percent with NDC 78835-008 is a a human over the counter drug product labeled by Eco-med Pharmaceuticals, Inc.. The generic name of Prevent Hydrogen Peroxide 3 Percent is hydrogen peroxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Eco-med Pharmaceuticals, 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 What 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.

Prevent Hydrogen Peroxide 3 Percent Active Ingredient(s)

What 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 .03 mL/mL

Inactive Ingredient(s)

About 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)

What 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.
  • 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

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eco-med Pharmaceuticals, Inc.
Labeler Code: 78835
FDA Application Number: part333A What 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. What 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: 10-26-2020 What 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: 12-31-2021 What 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 What 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.

Prevent Hydrogen Peroxide 3 Percent Product Label Images

Prevent Hydrogen Peroxide 3 Percent 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 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, mucus, 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 one week. Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

When Using This Product:

Do not get into eyes. Do not apply over large areas of the body. Do not use longer than one week unless directed by a doctor .

Stop Use And Ask A Doctor If:

Condition persists or gets worse.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.

In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions:

For first aid antiseptic use: Clean affected area, apply small amount of product on affected area 1-3 times a day. May be covered with a sterile bandage, If bandaged, let dry first, For 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 affected area for at least 1 minute and then spit out. Do not swallow. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. Children under 12 years 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 and in a dark place at room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient:

Purified water.

Questions:

1-844-432-6633 Mon- Fri 8am - 4 pm (EST) Email: info@eco-med.com

* Please review the disclaimer below.