Label: SULFUR soap

  • NDC Code(s): 11118-0009-1
  • Packager: Bradford Soap Works, 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 15, 2021

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

  • Active Ingredient

    Sulfur 5%

  • Purpose

    Acne Treatment

  • Indications & Usage

     For the treatment of acne. • Dries acne blemishes and allow skin to heal. • Helps prevent new acne blemishes from forming.

  • Warnings

    For external use only.

  • Keep out of reach of children

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

  • Stop use

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

  • Dosage & Administration 

    Apply soap to hands or wash cloth. • Gently was affected areas one to three times daily. • Leave on skin for several minutes, then rinse and pat dry. • If bothersome drying or peeling occurs, reduce application to once a day or every other day

  • Inactive ingredients

    Aloe vera leaf, alpha-bisabolol, chamomile (Matricaria recutita) flower extract, fo-ti (Polygonium multflorum) root extract, glycerin (vegetable), hawthorn (Crategus monogyna) berry extract, pentasodium pentetate, rosemary (Rosmarinus officinalis) leaf extract, sage (Salvia officinalis) aerial part extract, sodium chloride, sodium cocoate (coconut), sodium palmate, tetrasodium etidonate, water.

  • Dermaklear label

    3   59800 01070    3

    NDC 59800-0107-0

    ENZYMATIC dermaklear

    THERAPY

     dermaklear®

    Acne treatment soap

    Deep cleansing • active sulfur

    PLANT BASED • NET WT 3 OZ (85 g)

    Penetrates pores to control acne blemishes, whiteheads and blackheads

    No benzoyl peroxide to cause dry skin

    Drug Facts

    Active ingredient……Purpose

    Sulfur 5%.........Acne treatment

    Uses

    • For the treatment of acne. • Dries acne blemishes and allow skin to heal. • Helps prevent new acne blemishes from forming.

    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 on medication should be used unless directed by a doctor. • apply only to areas with acne.

    Do not use on: • broken skin. • large areas of skin.

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

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

    Directions

    • Apply soap to hands or wash cloth. • Gently was affected areas one to three times daily. • Leave on skin for several minutes, then rinse and pat dry. • If bothersome drying or peeling occurs, reduce application to once a day or every other day.

    Inactive ingredients

    Aloe vera leaf, alpha-bisabolol, chamomile (Matricaria recutita) flower extract, fo-ti (Polygonium multflorum) root extract, glycerin (vegetable), hawthorn (Crategus monogyna) berry extract, pentasodium pentetate, rosemary (Rosmarinus officinalis) leaf extract, sage (Salvia officinalis) aerial part extract, sodium chloride, sodium cocoate (coconut), sodium palmate, tetrasodium etidonate, water.

    ©2015 Distributed by Enzymatic Therapy Brands, LLC (part of Nature’s Way Brands, LLC), Green Bay, WI 54311 USA • Questions? 1-800-783-2286/enzy.com

    dermaklear®

    312428

    Dermaklear label

  • INGREDIENTS AND APPEARANCE
    SULFUR 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11118-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    ROSEMARY (UNII: IJ67X351P9)  
    SAGE (UNII: 065C5D077J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11118-0009-185 g in 1 CARTON; Type 0: Not a Combination Product01/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/04/2019
    Labeler - Bradford Soap Works, Inc. (001201045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bradford Soap Works, Inc.001201045manufacture(11118-0009) , label(11118-0009)