Label: MADINA ACNE- sulfur soap

  • NDC Code(s): 11118-0073-1
  • 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 June 6, 2023

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  • Drug Facts Active Ingredient:

    Sulfur 3%

  • Purpose

    Acne Treatment Soap

  • Uses:

    For relief and control of acne, pimples and blackheads.

  • Warnings:

    • For external use only
    • Do not get into eyes. if contact occurs, rinse eyes thoroughly with water
    • Using other acne medications in conjunction with this product may cause added irritation.
  • Keep out of reach of children.

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

  • Stop use and consult a physician

    if irritation continues or worsens.

  • Directions:

    When using this product for the first time, try it on a small area of skin to test for reaction. Wash areas where acne is present and allow soap to remain for a few minutes then rinse thoroughly with water.

  • Inactive ingredients:

    Sodium Palmate, Sodium Cocoate (OR) Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Sodium Chloride, Titanium Dioxide (Cl 77801), Butyrospermum Parki (Shea) Butter, Tetrasodium Etidronate, Pentasodium Pentetate, Tocopheryl Acetate, Green 8 (Cl 59040), Yellow 6 (Cl 15985), Yellow 10 (Cl 47005).

  • Madina Acne Treatment Cleansing Bar - product label

    311322

    1

    8 44586 00073 9

    SKIN CARE LABS

    ACNE TREATMENT CLEANSING BAR

    Madina Skin Care Labs Deep Cleaning Acne Treatment Soap helps control Acne, pimples and blackheads. Contains Shea Butter and Vitamin E to moisturize and strengthen skin. Natural sulfur aroma will dissipate after use.

    mADinA

    PALM OIL

    MADINA®

    SKIN CARE LABS

    ACNE TREATMENT CLEANSING BAR

    With 3% Sulfur for Deep Cleansing

    3.5 oz. (100g NET. WT.)

    SKIN CARE LABS

    ACNE TREATMENT CLEANSING BAR

    Madina Skin Care Labs Deep Cleaning Acne Treatment Soap helps control Acne, pimples and blackheads. Contains Shea Butter and Vitamin E to moisturize and strengthen skin. Natural sulfur aroma will dissipate after use.

    Drug Facts

    Active Ingredient……………………..…Purpose

    3% Sulfur…………………………………Acne Treatment Soap

    Uses: For relief and control of acne, pimples and blackheads.

    Warnings:

    • § For external use only.
    • § Do not get into eyes. If contact occurs, rinse eyes thoroughly with water
    • § Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
    • § Using other acne medications in conjunction with this product may cause added irritation.
    • § Stop use and consult a physician if irritation continues or worsens.

    Directions:

    When using this product for the first time, try it on a small area of skin to test for reaction. Wash areas where acne is present and allow soap to remain for a few minutes then rinse thoroughly with water.

    Inactive ingredients:

    Sodium Palmate, Sodium Cocoate (OR) Sodium Palm Kernelate, Water (Aqua) Glycerin, Fragrance (Parfum), Sodium Chloride, Titanium Dioxide (CI77891), Butyrospermium Parkii (Shea) Butter, Tetrasodium Etidronate, Pentasodium Pentetate, Tocopheryl Acetate, Green 8 (CI 59040), Yellow 6 (CI15985), Yellow 10 (CI 47005).

    MADINA INDUSTRIAL CORP.

    Brooklyn NY 11217 • USA

    ©2013 All Rights Reserved

    Questions or Comments

    info@madinaonline.com

    www.madinaonline.com

    This Name & Design is a registered Trademark with U.S. Pat and TM Officials

    Bradfordsoap Madina Cleansing Bar

  • INGREDIENTS AND APPEARANCE
    MADINA ACNE 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11118-0073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C GREEN NO. 8 (UNII: I2W85YOX9L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11118-0073-1100 g in 1 CARTON; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/01/2017
    Labeler - Bradford Soap Works, Inc. (001201045)
    Registrant - Bradford Soap Works, Inc. (001201045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bradford Soap Works, Inc.001201045manufacture(11118-0073)
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