Label: DE LA CRUZ SULFUR ACNE MEDICATION- sulfur ointment

  • NDC Code(s): 24286-1525-2, 24286-1525-3, 24286-1525-4
  • Packager: DLC Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 27, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sulfur, 10%

  • Purpose

    Acne medication

  • Uses

    for the treatment of acne

    • penetrates the pores and dries and clears acne pimples and blackheads
    • helps to keep new acne pimples and blackheads from forming
  • Warnings

    For external use only

    Do not use on

    • broken skin
    • large areas of the skin

    When using this product

    • do not get into eyes
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time or right after use of this product. If irritation occurs, only use one topical acne medication at a time.
    • apply only to areas with acne

    Stop use and consult a doctor if excessive skin irritation develops or increases.

    Keep out of the reach of children.

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

  • Directions

    • cleanse the skin thoroughly before applying
    • cover the entire affected area with a thin layer
    • leave on for 10 minutes
    • thoroughly remove with water
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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
  • Inactive ingredient

    polyethylene glycol

  • Questions?

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    De La Cruz Products
    A Division of DLC Laboratories, Inc.
    Paramount, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 73.7 g Jar Label

    De La Cruz ®

    MAXIMUM STRENGTH

    SULFUR
    OINTMENT
    10%

    Acne Medication

    2.6 OZ (73.7 g)

    PRINCIPAL DISPLAY PANEL - 73.7 g Jar Label
  • INGREDIENTS AND APPEARANCE
    DE LA CRUZ SULFUR ACNE MEDICATION 
    sulfur ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1525
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1525-273.7 g in 1 JAR; Type 0: Not a Combination Product08/11/2014
    2NDC:24286-1525-32.8 g in 1 POUCH; Type 0: Not a Combination Product03/17/2015
    3NDC:24286-1525-46 g in 1 JAR; Type 0: Not a Combination Product03/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/11/2014
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1525) , LABEL(24286-1525)