NDC 49681-016 New Life 3% Hydrogen Peroxide First Aid Antiseptic

Hydrogen Peroxide

NDC Product Code 49681-016

NDC CODE: 49681-016

Proprietary Name: New Life 3% Hydrogen Peroxide First Aid Antiseptic What 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 What 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.

NDC Code Structure

NDC 49681-016-04

Package Description: 118 mL in 1 BOTTLE

NDC 49681-016-16

Package Description: 473 mL in 1 BOTTLE

NDC 49681-016-32

Package Description: 946 mL in 1 BOTTLE

NDC Product Information

New Life 3% Hydrogen Peroxide First Aid Antiseptic with NDC 49681-016 is a a human over the counter drug product labeled by New Life Products, Inc.. The generic name of New Life 3% Hydrogen Peroxide First Aid Antiseptic is hydrogen peroxide. The product's dosage form is solution and is administered via topical form.

Labeler Name: New Life Products, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

New Life 3% Hydrogen Peroxide First Aid Antiseptic 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.


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.

Product Labeler Information

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

Labeler Name: New Life Products, Inc.
Labeler Code: 49681
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: 02-05-2021 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: 12-31-2022 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.

New Life 3% Hydrogen Peroxide First Aid Antiseptic Product Label Images

New Life 3% Hydrogen Peroxide First Aid Antiseptic 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%


First aid antiseptic/oral debriding agent


• 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.


• For external use only. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.Do not use: In the eyes or apply over large areas of the body • Longer than one weekAsk a doctor before use if you have deep or puncture wounds, animal bites or serious burns.Stop use and ask a doctor if swelling, rash, or fever develops • the condition persists or gets worse • sore mouth symptoms do not improve in 7 days • irritation, pain, redness persists or worsens

Otc - Keep Out Of Reach Of Children



• For use as a first aid antiseptic:• clean affected area • apply small amount of product on affected area 1 to 3 times a day • if bandaged, let dry first • may be covered with a sterile bandageFor use as an 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. Do not swallow.• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctorChildren under 12 years should be supervised in the use of this product.Children under 2 years of age: consult a doctor or dentist.

Other Information

• Keep tightly closed and in a dark place at room temperature • Do not shake bottle. Hold away from face when opening.

Inactive Ingredients:

Purified water.

* Please review the disclaimer below.