Label: JOESOEF SKINCARE ANTI ACNE- sulfur lotion

  • 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 February 25, 2020

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients                     Purpose

    Precipitated Sulfur 6.6%..............Acne medication

  • PURPOSE

    Use for the treatment of acne. Penetrades pores to clear most acne blemishes, acne pimples, blackhead, and whiteheads. Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

    In case of incidental ingestion, get medical help or contact a poison control center immediately.

  • INDICATIONS & USAGE

    Directions

    • Cleanse the skin thoroughly before applying medication.
    • Using a cotton swab, cover the entire effected area with a thin layer one to three times daily.
    • Because excessive drying of the skim 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.
    • Shake well before use
  • WARNINGS

    Warnings

    For external use only

  • DOSAGE & ADMINISTRATION

    When using this product

    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
    • Do not get into eyes. If excessive skin irridation develops or increases, discontinue use and consult a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified water, Ethyl alcohol, DMDM Hydantoin, Cabomer, Fragrance, Triethanolamine, Calcium oxide.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    JOESOEF SKINCARE ANTI ACNE 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26050-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6.3   in 95 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26050-112-0195 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2006
    Labeler - PT Galenium Pharmasia Laboratories (726631497)
    Establishment
    NameAddressID/FEIBusiness Operations
    PT Galenium Pharmasia Laboratories726631497manufacture(26050-112)