Label: ANTI ACNE NATURAL VOLCANIC SULFUR- sulfur soap

  • 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 28, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Precipitated Sulfur 10%

  • Purpose

    Acne medication

  • Use

    for the treatment of acne.

  • Warnings

    For external use only

    When using this product

    • 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.
    • Do not use on large areas of skin.
    • Do not get into eyes. If excessive skin Irritation develops or increases, discontinue use and consult a doctor.

    Keep out of reach of children.

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

  • Directions

    • Work up a lather using warm water and apply to affected area.
    • Rinse thoroughly and pat dry.
    • 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.
  • Inactive ingredients

    Saponified Palm and Palm Kernel Oil, Lanolin, Fragrance, Coconut Fatty Acid Diethanol Amide, Salicylic Acid 0.25%, Glycerin, Titanium Dioxide.

  • Questions or Comments

    888-406-0151

  • SPL UNCLASSIFIED SECTION

    Distributed by Dr. Joesoef Skin Care, LLC.
    Boca Raton, Florida 33433 USA

  • PRINCIPAL DISPLAY PANEL - 100 g Box

    SULFUR 10%

    NEW!

    Joesoef™
    SKIN CARE

    Anti-Acne Soap
    Natural Volcanic Sulfur 10%

    For Oily to Normal Skin

    Formulated & Developed
    by Dermatologists for:

    • Treatment of Acne
    • Clogged pores
    • Blackheads
    • Blemishes

    Net wt. 3.5 oz (100g)

    Principal Display Panel - 100 g Box
  • INGREDIENTS AND APPEARANCE
    ANTI ACNE NATURAL VOLCANIC SULFUR 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26050-101
    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
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    LANOLIN (UNII: 7EV65EAW6H)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26050-101-01100 g in 1 BOX; Type 0: Not a Combination Product10/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2012
    Labeler - PT. GALENIUM PHARMASIA LABORATORIES (726631497)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galenium Pharmasia Laboratories, PT726631497manufacture(26050-101)
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