FDA.reportPublic FDA data

Margarite Zinc Cream

Manufacturer
Renu Laboratories, LLC
Effective date
2025-06-10
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:02:45

Label at a glance#

ProductMargarite Zinc Cream
Active ingredientSULFUR
Label structure11 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sulfur 4%

OTC - DO NOT USE SECTION

Do not use on

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

OTC - PURPOSE SECTION

Purpose

Acne Treatment

OTC - QUESTIONS SECTION

1.800.644.1466

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

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

Warnings

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of the reach of children.

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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.

INDICATIONS & USAGE SECTION

Uses

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TUBE ART FOR MARGARITE ZINC CREAM

Margarite TubeMargarite Tube

Margarite BOX

Margarite zinc cream boxMargarite zinc cream box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247817sulfur 4 % Topical CreamPSN11
247817sulfur 40 MG/ML Topical CreamSCD11
247817sulfur 4 % Topical CreamSY11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-413-022025-06-10C16284748780-12cef2736-5b8b-d83d-e063-dadaa90ab31fMARGARITE ZINC CREAM
76348-413-022025-01-30C16284748780-12cef2736-5b8b-d83d-e063-dadaa90ab31fMARGARITE ZINC CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-413-01Margarite Zinc Cream28 g in 1 TUBECREAM2811
76348-413-02Margarite Zinc Cream1 in 1 BOXCREAM111

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-41376348-413-01, 76348-413-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERROUS OXIDEG7036X8B5HIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BENTONITEA3N5ZCN45CIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CASTOR OILD5340Y2I9GIACT
CANDELILLA WAXWL0328HX19IACT
ZINC OXIDESOI2LOH54ZIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
SULFUR70FD1KFU70ACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Margarite Zinc CreamZINC CREAMRenu Laboratories, LLC3ca3b7d8-702a-036b-e054-00144ff8d46c2025-06-10WarningsExact identifier
ndc (package): 76348-413-02
ndc (package): 76348-413-01
ndc (product): 76348-413
ndc11 (package): 76348041301
ndc11 (package): 76348041302
spl id: 373b8aa5-564e-3e75-e063-6394a90af372
spl set id: 3ca3b7d8-702a-036b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.