NDC 55910-871 Hydrogen Peroxide

Hydrogen Peroxide

NDC Product Code 55910-871

NDC 55910-871-38

Package Description: .295 L in 1 BOTTLE, PLASTIC

NDC 55910-871-43

Package Description: .473 L in 1 BOTTLE, PLASTIC

NDC 55910-871-45

Package Description: .946 L in 1 BOTTLE, PLASTIC

NDC 55910-871-72

Package Description: .295 L in 1 BOTTLE, SPRAY

NDC Product Information

Hydrogen Peroxide with NDC 55910-871 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Hydrogen Peroxide is hydrogen peroxide. The product's dosage form is solution and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 91349.

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.

Hydrogen Peroxide 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: Dolgencorp, Llc
Labeler Code: 55910
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: 11-15-1989 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hydrogen Peroxide Product Label Images

Hydrogen Peroxide 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

As 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 affected area 1 to 3 times a day•may be covered with a sterile bandage•if bandaged, let dry firstOral debriding agent 9oral 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 and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive Ingredient

Purified water

Adverse Reactions

Distributed byOld East Main100 MISSION RIDGEGOODLETTSVILLE, TN 37072871.000/871AA

* Please review the disclaimer below.