NDC 70000-0022 Hydrogen Peroxide

Hydrogen Peroxide

NDC Product Code 70000-0022

NDC Product Information

Hydrogen Peroxide with NDC 70000-0022 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Hydrogen Peroxide is hydrogen peroxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Cardinal Health

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.


Hydrogen Peroxide 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 1 mL/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: Cardinal Health
Labeler Code: 70000
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: 03-19-2019 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.

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 antisepticOral 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 eyes or apply over large areas of the bodylonger 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 worsesore mouth symptoms do not improve in 7 daysirritation, pain, or redness persists or worsensswelling, 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 antisepticclean the affected areaapply a small amount of product on the affected area 1 to 3 times a dayirritation, pain or redness persists or worsensswelling, rash, or fever developsOral debriding agent (oral rinse): adults and children 2 years of age and over:mix with an equal amount of waterswish around in the mouth over the affected area for at least 1 minute and then spit outuse up to 4 times daily after meals and at bedtime or as directed by a dentistchildren under 12 years of age should be supervised in the use of this productchildren 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

Questions

1-800-593-0593

Adverse Reactions

Dist. by CAH, Dublin, OH 430172019 Cardinal Health100% Money Back GuaranteeReturn to place of purchase if not satisfied871.001/871AA

* Please review the disclaimer below.

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