Label: GRANDPAS THYLOX ACNE TREATMENT WITH SULFUR- sulfur soap

  • NDC Code(s): 11118-1006-6
  • 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 4, 2019

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  • Drug FactsActive Ingredient

    Sulfur  3.0%

    Purpose

    Acne Treatment Soap

  • Uses

    Acts four ways to improve blemished skin:

    • Softens the hard shell of acne blemishes (keratolytic action).
    • Helps dissolve and remove blackheads.
    • Washes away excess oils which may cause blackheads. 
    • Freshens skin by its thorough cleansing action.

    Warings

    For external use only. Using other topical acne medications at the same time or immediately following the 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.

    Stop use and ask a doctor if

    excessive skin irritation develpoes or increases.

  • Keep out of reach of children

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

  • Directions

    Use twice daily. Work up a lather with hands or washcloth and apply to affected areas without scrubbing. Let dry about one minute, rinse thoroughly, and pat dry.

  • Inactive Ingredients

    Sodium Palmate, Sodium Cocoate*, Water, Glycerin, Fragrance, Titanium Dioxide, Tetrasodium Etidronate, Pentasodium Pentetate, Cosmetic Orange oxide. * May also contain Sodium Palm Kernelate.

  • PRINCIPAL DISPLAY PANEL

    THYLOX®

    ALL NATURAL, 100% VEGETABLE BASE

    ACNE TREATMENT

    WITH 3% SULFUR

    Drug Facts

    Active Ingredient          Purpose

    Sulfur 3%. .. Acne Treatment Soap

    Uses

    • § For the treatment of acne.

    Warnings

    For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation to the skin. If this occurs, only on medication should be used unless directed by a doctor. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    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 immediately.

    Directions Work up a lather and gently massage into affected areas. Leave on for one minute, rinse thoroughly, and pat dry. Use morning and night for best results.

    Inactive ingredients Sodium Palmate®, Sodium Cocoate/Sodium Palm Kernelate, Water (Aqua), Glycerin, Jasminum Officinale (Jasmine) Oil, Cananga Odorata Leaf Oil, Glyine Soja (Soybean) Oil, Sodium Chloride, Sodium Gluconate

    AN AGE-OLD TREATMENT FOR TROUBLED SKIN

    Ideal for skin prone to acne and inflammation, this treatment soap harnesses the healing properties of natural sulfur to prevent and eliminate breakouts, blackheads and excess oil.

    Also phthalates, sulfates, parabene, edta, gluten, animal by-products, artificial fragrances or colorants

    THE GRANDPA  SOAP COMPANY

    THE GRANDPA SOAP CO.

    THYLOX®

    ACNE TREATMENT

    FROM OUR FAMILY TO YOURS

    SINCE 1878

    3% SULFUR

    HARDWORKING, SIMPLE, PURE INGREDIENTS ARE THE HEART OF OUR NATURALSOAPMAKING TRADITION

    FROM OUR FAMILY TO YOURS

    NET WT 3.25 OZ (926)

    FACE

    & BODY BAR SOAP

    Thylox Soap

  • INGREDIENTS AND APPEARANCE
    GRANDPAS THYLOX ACNE TREATMENT WITH SULFUR 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11118-1006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PALM OIL (UNII: 5QUO05548Z)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11118-1006-692 g in 1 BOX; Type 0: Not a Combination Product02/20/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/20/2007
    Labeler - Bradford Soap Works, Inc. (001201045)
    Registrant - Bradford Soap Works, Inc. (001201045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bradford Soap Works, Inc.001201045manufacture(11118-1006) , label(11118-1006)