Label: DERMAKLEAR AKNE TREATMENT WITH SULFUR- sulfur soap

  • NDC Code(s): 59800-0107-0
  • Packager: Schwabe North America, 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 November 14, 2019

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

  • DermaKlear

    ACTIVE INGREDIENTS:

    Sulfur 5%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT:

    Aloe vera leaf

    alpha-bisabolol
    Chamomile flower extract
    fo-ti root extract
    glycerin (vegetable)
    Hawthorn berry extract 
    Pentasodium pentetate
    Rosemary leaf extract
    Sage aerial part extract
    Sodium chloride
    Sodium cocoate (coconut)
    Sodium palmate

    Tetrasodium etidronate
    Water

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Directions: Apply soap to hands or wash cloth. 

    Gently wash affected areas one to three times daily. 

    Leave on skin for several minutes. 

    Rinse and pat dry. 

    If bothersome drying or peeling occurs, reduce application to once a day or every other day.

  • INDICATIONS & USAGE

    Indications and Usage:

    For the treatment of acne. 

    Dries acne blemishes and allows skin to heal. 

    Helps prevent new acne blemishes from forming.

  • WARNINGS

    Warnings:

    For external use only.

    When using this product do not get into eyes; dryness or irritation of the skin may increase if other topical acne medications are used at the same time or immediately following use of this product. 

    If this occurs only one medication should be used unless directed by a doctor.

    Apply only to areas with acne.

    Do Not Use on broken skin or large areas of skin.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children:

    Keep out of reach of children.  If swallowed, seek medical hlep or contact a Poison Control Center immediately

  • ASK DOCTOR

    Ask the Doctor:

    When using this product do not get into eyes; dryness or irritation of the skin may increase if other topical acne medications are used at the same time or immediately following use of this product. 

    If this occurs only one medication should be used unless directed by a doctor.

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

  • OVERDOSAGE

    Overdosage:

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

  • PURPOSE

    Purpose:

    Uses for the treatment of acne. 

    Dries acne blemishes and allows skin to heal. 

    Helps prevent new acne blemishes from forming.

  • PRINCIPAL DISPLAY PANEL

    DermaKlear _01070_D01.jpg

    DermaKlear _01070_D01.jpg

  • INGREDIENTS AND APPEARANCE
    DERMAKLEAR AKNE TREATMENT WITH SULFUR 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59800-0107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    ROSEMARY (UNII: IJ67X351P9)  
    SAGE (UNII: 065C5D077J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    WATER (UNII: 059QF0KO0R)  
    POLYGONATUM MULTIFLORUM ROOT (UNII: EYW899536C)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    CRATAEGUS MONOGYNA FRUIT (UNII: KJI2JZT1TS)  
    Product Characteristics
    Colorwhite (DERMA KLEAR) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59800-0107-01 in 1 BOX07/01/2004
    185 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/01/2004
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bradford Soap Works, Inc001201045manufacture(59800-0107)