NDC 70764-107 Clear Med 10%
Benzoyl Peroxide Lotion Topical

Product Information

What is NDC 70764-107?

The NDC code 70764-107 is assigned by the FDA to the product Clear Med 10% which is a human over the counter drug product labeled by Control Corrective Skincare Inc. The generic name of Clear Med 10% is benzoyl peroxide. The product's dosage form is lotion and is administered via topical form. The product is distributed in a single package with assigned NDC code 70764-107-51 1 tube in 1 box / 74 ml in 1 tube (70764-107-11). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code70764-107
Proprietary Name 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.
Clear Med 10%
Non-Proprietary Name 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.
Benzoyl Peroxide
Product Type 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.
Human Otc Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Control Corrective Skincare Inc
Labeler Code70764
FDA Application Number 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.
part333D
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-09-2016
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Clear Med 10%?


Product Packages

NDC Code 70764-107-51

Package Description: 1 TUBE in 1 BOX / 74 mL in 1 TUBE (70764-107-11)

Product Details

What are Clear Med 10% Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BENZOYL PEROXIDE 5 g/100mL - A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.

Clear Med 10% Active Ingredients UNII Codes

Clear Med 10% Inactive Ingredients UNII Codes

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.

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Clear Med 10% Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients



BENZOYL PEROXIDE 10%


Purpose



ACNE TREATMENT


Use



HELPS REDUCE ACNE BREAKOUTS.


Warnings



FOR EXTERNAL USE ONLY. DO NOT USE IF YOU ARE ALLERGIC OR SENSITIVE TO BENZOYL PEROXIDE. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES, LIPS AND MOUTH. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. AVOID UNNECESSARY SUN EXPOSURE. MAY BLEACH FABRIC. MILD IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION. DISCONTINUE USE, IF IRRITATION OCCURS AND CONSULT YOUR DOCTOR. USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN.


Directions



ALWAYS PATCH TEST A SMALL AREA BEFORE FIRST APPLICATION. APPLY SPARINGLY TO AFFECTED AREAS ONCE OR TWICE DAILY AS NEEDED, AVOIDING THE EYE AREA. DRYNESS AND LIGHT PEELING MAY OCCUR DURING THE FIRST FEW WEEKS OF USAGE.


Inactive Ingredients



WATER, SULFUR 3%, BUTYLENE GLYCOL, CARBOMER, POTASSIUM SORBATE, PHENOXYETHANOL, SODIUM BENZOATE, SODIUM HYDROXIDE.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Questions Or Comments:



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