MedPath

Margarite Zinc Cream

MARGARITE ZINC CREAM

Approved
Approval ID

3ca3b7d8-702a-036b-e054-00144ff8d46c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

Renu Laboratories, LLC

DUNS: 119451815

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Cream

PRODUCT DETAILS

NDC Product Code76348-413
Application NumberM006
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateJune 10, 2025
Generic NameZinc Cream

INGREDIENTS (14)

WATERInactive
Quantity: 20.7 g in 28 g
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
BENTONITEInactive
Code: A3N5ZCN45C
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
ZINC OXIDEInactive
Code: SOI2LOH54Z
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
SULFURActive
Quantity: 1.12 g in 28 g
Code: 70FD1KFU70
Classification: ACTIB
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/15/2013

TUBE ART FOR MARGARITE ZINC CREAM

Margarite Tube

Margarite BOX

![Margarite zinc cream box](/dailymed/image.cfm?name=2016_Final_Zinc_Cream- Box1+%282%29_9.16.16.jpg&id=880594)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/13/2015

Uses

*treats acne *dries up acne pimples *helps prevent new acne pimples

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/15/2013

Active ingredient

Sulfur 4%

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 10/15/2013

Do not use on

  • broken skin
  • large areas of the skin
  • eyes and mouth

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/13/2015

Purpose

Acne Treatment

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/15/2013

1.800.644.1466

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 10/15/2013

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 10/15/2013

When Using this Product

  • apply only to areas with acne
  • 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.

WARNINGS SECTION

LOINC: 34071-1Updated: 10/15/2013

Warnings

For external use only

  • Keep out of the reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/15/2013

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/15/2013

Directions

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

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Margarite Zinc Cream - FDA Drug Approval Details