NDC 76348-413 Margarite Zinc Cream

Zinc Cream

NDC Product Code 76348-413

NDC 76348-413-02

Package Description: 1 TUBE in 1 BOX > 28 g in 1 TUBE (76348-413-01)

NDC Product Information

Margarite Zinc Cream with NDC 76348-413 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Margarite Zinc Cream is zinc cream. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 247817.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Margarite Zinc Cream 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.


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)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERROUS OXIDE (UNII: G7036X8B5H)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • BENTONITE (UNII: A3N5ZCN45C)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CETYL ALCOHOL (UNII: 936JST6JCN)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 10-13-2015 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: 12-31-2021 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 - NO 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".

* Please review the disclaimer below.

Margarite Zinc Cream 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

Otc - Active Ingredient

Active ingredientSulfur 4%

Otc - Do Not Use

  • Do not use onbroken skinlarge areas of the skineyes and mouth

Otc - Purpose

PurposeAcne Treatment

Otc - Questions

1.800.644.1466

Otc - Stop Use

If excessive skin irritation develops or increases, discontinue use and consult a doctor.

Otc - When Using

  • When Using this Productapply only to areas with acneskin 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.

Warnings

WarningsFor external use only

Otc - Keep Out Of Reach Of Children

  • Keep out of the reach of children.

Inactive Ingredient

Inactive Ingredients:Water, Zinc Oxide (10%), Cetearyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Cetyl Alcohol, Glyceryl Stearate, Titanium Dioxide, Vegetable Oil (Castor), Hydrogenated Vegetable Oil (Castor), Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Bentonite, Phenoxyethanol, Iron Oxides.

Directions

  • Cleanse the skin thoroughly before applying ZINC CREAM FOR PROBLEM SKIN.Cover the entire affected area up to three times dailyBecause 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. ZINC CREAM FOR PROBLEM SKIN can be used under make-up or moisturizer.

Indications & Usage

  • Usestreats acnedries up acne pimpleshelps prevent new acne pimples

* Please review the disclaimer below.