NDC 10742-1203 Oxy Advanced Care Sensitive Skin Acne Cleanser
Benzoyl Peroxide Gel Topical

Product Information

Oxy Advanced Care Sensitive Skin Acne Cleanser is a human over the counter drug product labeled by The Mentholatum Company. The generic name of Oxy Advanced Care Sensitive Skin Acne Cleanser is benzoyl peroxide. The product's dosage form is gel and is administered via topical form.

Product Code10742-1203
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.
Oxy Advanced Care Sensitive Skin Acne Cleanser
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 FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.
The Mentholatum Company
Labeler Code10742
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.
09-20-2021
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.
12-31-2022
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 Oxy Advanced Care Sensitive Skin Acne Cleanser?


Product Packages

NDC 10742-1203-1

Package Description: 148 mL in 1 TUBE

NDC 10742-1203-2

Package Description: 170 mL in 1 TUBE

Product Details

What are Oxy Advanced Care Sensitive Skin Acne Cleanser 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 50 mg/mL - 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.

Oxy Advanced Care Sensitive Skin Acne Cleanser Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Oxy Advanced Care Sensitive Skin Acne Cleanser 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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Patient Education

Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)

Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
[Read More]

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Oxy Advanced Care Sensitive Skin Acne Cleanser Labeling and Warnings

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.

Table of Contents



Active Ingredient



Benzoyl peroxide 5%


Purpose



Acne treatment


Uses



  • •for the treatment of acne
  • •clears acne pimples and allows skin to heal
  • •penetrates pores to control blackheads and whiteheads
  • •helps prevent new acne pimples from forming

Warnings



For external use only


Do Not Use If You



  • •have very sensitive skin
  • •are sensitive to benzoyl peroxide

When Using This Product



  • •skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • •avoid unnecessary sun exposure and use a sunscreen
  • •avoid contact with the eyes, lips, and mouth
  • •avoid contact with hair and dyed fabrics, which may be bleached by this product
  • •skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop Use And Ask A Doctor If



irritation becomes severe


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • •wet face
  • •apply to hands then massage gently onto face
  • •rinse thoroughly and pat dry
  • •because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
  • •if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • •if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information



  • •THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
  • •KEEP TIGHTLY CLOSED
  • •avoid storing at temperatures above 100°F (38°C)

Inactive Ingredients



water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, chlorphenesin, citric acid, glycerin, hydrolyzed soy protein, PEG-8 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate


Questions?



1-877-636-2677 MON-FRI 9 AM-5 PM (EST)


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