NDC 10742-1314 Oxy Total Care Clarifying Moisturizer

Benzoyl Peroxide

NDC Product Code 10742-1314

NDC 10742-1314-1

Package Description: 1 TUBE in 1 CARTON > 100 mL in 1 TUBE

NDC Product Information

Oxy Total Care Clarifying Moisturizer with NDC 10742-1314 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Oxy Total Care Clarifying Moisturizer is benzoyl peroxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: The Mentholatum Company

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 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.

Oxy Total Care Clarifying Moisturizer 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.

  • BENZOYL PEROXIDE 25 mg/mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • ALGINIC ACID (UNII: 8C3Z4148WZ)
  • LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
  • PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FYTIC ACID (UNII: 7IGF0S7R8I)
  • PURSLANE (UNII: M6S840WXG5)
  • SILANETRIOL (UNII: E52D0J3TS5)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)

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: The Mentholatum Company
Labeler Code: 10742
FDA Application Number: part333D 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-30-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Oxy Total Care Clarifying Moisturizer Product Label Images

Oxy Total Care Clarifying Moisturizer 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

Benzoyl peroxide 2.5%

Purpose

Benzoyl peroxide – Acne treatment

Keep Out Of Reach Of Children

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

Uses

  • •For the treatment of acne. •Helps prevent new acne blemishes.

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, use only 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.

Directions

  • •clean the skin thoroughly before applying this product •use a dime-sized amount to cover the entire affected area with a thin layer one to two times daily •because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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. •Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.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, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, hyaluronic acid, hydrolyzed algin, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, phytic acid, portulaca oleracea extract, silanetriol, sodium citrate, sodium hydroxide, xanthan gum, zinc sulfateQuestions?1-877-636-2677MON-FRI 9AM-5PM (EST)

* Please review the disclaimer below.