Hydrogen Peroxide
Cardinal Health
Human Otc Drug
NDC 63517-450Hydrogen Peroxide is a human otc drug labeled by 'Cardinal Health'. National Drug Code (NDC) number for Hydrogen Peroxide is 63517-450. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Hydrogen Peroxide drug includes Hydrogen Peroxide - 30 mg/mL . The currest status of Hydrogen Peroxide drug is Active.
Drug Information:
| Drug NDC: | 63517-450 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hydrogen Peroxide |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydrogen Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROGEN PEROXIDE - 30 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jun, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Cardinal Health
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 91349
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | BBX060AN9V
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63517-450-26 | 118 mL in 1 BOTTLE, PLASTIC (63517-450-26) | 01 Jun, 2015 | N/A | No |
| 63517-450-34 | 237 mL in 1 BOTTLE, PLASTIC (63517-450-34) | 01 Jun, 2015 | N/A | No |
| 63517-450-43 | 473 mL in 1 BOTTLE, PLASTIC (63517-450-43) | 01 Jun, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose first aid antiseptic oral debriding agent
Product Elements:
Hydrogen peroxide hydrogen peroxide hydrogen peroxide hydrogen peroxide water
Indications and Usage:
Use 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 occassional sore mouth
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
Dosage and Administration:
Directions first aid antiseptic: clean the affected area apply a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first oral debriding agent: adults, children over 2 years of age mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor
Stop Use:
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
Package Label Principal Display Panel:
Principal display panel ndc 63517-450-43 hydrogen peroxide 3% first aid antiseptic oral debriding agent do not use if package opened or damaged temperature limitation 68°f - 77°f 20°c - 25°c not made with natural rubber latex for individual, professional, and hospital use cat. as-hpl16 distributed by: cardinal health waukegan, il 60085 usa cardinalhealth.com 05/15 2015 cardinal health. all rights reserved. cardinal health and the cardinal health logo are trademarks of cardinal health. cardinalhealth 16 fl oz (1 pt) 473 ml image description