Label: RENU LABORATORIES ACNE SULPHUR L- acne sulfur lotion suspension

  • NDC Code(s): 76348-450-02
  • Packager: Renu Laboratories, 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 January 17, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sulfur Colloidal (10%)

  • PURPOSE

    Purpose

    Topical Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • for the treatment of acne
    • healing and drying acne breakouts
    • helps clear acne pimples, blackheads or whiteheads and allows skin to heal
    • penetrates pores to control acne blemishes
    • helps keep skin clear of new acne pimples

  • WARNINGS

    Warnings

    For external use only

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
      If irritation occurs, only use one topical acne medication at a time.
  • DO NOT USE

    Do Not Use

    • on broken skin
    • on large areas of the skin
    • if pregnant or breast-feeding, ask a health professional before use.
  • WHEN USING

    When using this product

    • apply only to areas with acne
  • STOP USE

    Stop use and ask a doctor if

    • excessive dryness or peeling occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well
    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed
      by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • INACTIVE INGREDIENT

    Inactive ingredients

    Camphor, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid, Zinc Oxide.

  • PRINCIPAL DISPLAY PANEL

    Renu Sulfur Lotion

  • INGREDIENTS AND APPEARANCE
    RENU LABORATORIES ACNE SULPHUR L 
    acne sulfur lotion suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1.4 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    Colorwhite (Suspension) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-450-0256 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/16/2015
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-450)
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