MALIN AND GOETZ ACNE TREATMENT (SULFUR) CREAM [MALIN AND GOETZ INC]

MALIN AND GOETZ ACNE TREATMENT (SULFUR) CREAM [MALIN AND GOETZ INC]
PDF | XML

NDC 53634-010-01, 53634-010-02
Set ID 47390813-6bc9-44f4-b72a-d399d2c0de27
Category HUMAN OTC DRUG LABEL
Packager Malin and Goetz Inc
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENT

    Active ingredient purpose

    Sulfur 10% Acne Treatment

    Uses

    treats acne

    dries up acne pimples

    helps prevent acne pimples

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

    Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

    Warnings

    For External Use only

    Do not use on Broken Skin

    When using this product

    -Apply to affected areas only

    -do not use in or near the eyes

    -using other topical acne medication at the same time or right after the use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor.

    Directions

    -do not shake solution

    -lean the skin thoroughly before applying

    -dip clean cotton swab into sediment and apply directly to blemishes

    -because too much drying of the skin may occur, start with 1 application daily then gradually increase to 2 or 3 daily if needed or as directed by a doctor

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

    Inactive Ingredients

    Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Salicylic Acid, Magnesium Aluminum Silicate

  • PRINCIPAL DISPLAY PANEL

    (Malin + Goetz)

    acne treatment Nighttime

    10% Sulfur lotion. Overnight Treatment

    .5 fl. oz. 14ml

    image of carton

    image of jar

  • INGREDIENTS AND APPEARANCE
    MALIN AND GOETZ  ACNE TREATMENT
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53634-010-021 in 1 CARTON11/05/2012
    1NDC:53634-010-0114.75 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/05/2012
    Labeler - Malin and Goetz Inc (138615930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(53634-010)

Related Drugs