Label: EARTHS CARE ACNE SPOT TREATMENT- sulfur cream

  • NDC Code(s): 24286-1557-1, 24286-1557-2
  • 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 January 11, 2022

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  • 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 pimples and blackheads
    • helps to keep new pimples and blackheads from forming
  • Warnings

    For external use only

    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. If irritation occurs, only use one topical acne medication at a time.
    • apply only to areas with acne

    Do not use on

    • broken skin
    • large areas of the skin

    Stop use and ask a doctor if

    • excessive skin irritation develops or increases

    Keep out of 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 one to three times daily
    • 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 ingredients

    Avena sativa (oat) kernel colloidal oatmeal, bentonite, Butyrospermum parkii (shea) butter, cetearyl glucoside, citric acid, glycerin, glyceryl stearate, Helianthus annuus (sunflower) seed oil, hydrogenated castor oil, phenoxyethanol, potassium sorbate, purified water, sodium stearoyl glutamate, xanthan gum

  • Questions

    1-888-602-6380

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Earth's Care Natural Products, Inc.
    Long Beach, California 90805 USA

  • PRINCIPAL DISPLAY PANEL - 27 g Tube Box

    Allergy Tested

    EARTH'S CARE ®

    * PARABEN * FREE

    Acne Spot Treatment

    Maximum Strength

    Sulfur 10%

    Clears and Helps Prevent
    Stubborn Blemishes

    with Natural Bentonite
    and Colloidal Oatmeal

    Non-Comedogenic

    1% FOR THE PLANET SM MEMBER

    0.97 OZ. (27 g) Acne-Spot-treatment

  • INGREDIENTS AND APPEARANCE
    EARTHS CARE ACNE SPOT TREATMENT 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1557
    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
    OATMEAL (UNII: 8PI54V663Y)  
    BENTONITE (UNII: A3N5ZCN45C)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1557-11 in 1 BOX01/18/2013
    127 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:24286-1557-22.8 g in 1 POUCH; Type 0: Not a Combination Product01/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/18/2013
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930manufacture(24286-1557)
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