Label: ADARA ACNE 911 DRYING- acne drying lotion suspension

  • NDC Code(s): 76348-890-01
  • Packager: Renu Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 14, 2023

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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

    Do Not Shake

    • clean skin thoroughly before applying this product
    • carefully place wand or cotton swab into sediment at bottom and apply directly to the blemish
    • 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

    BOTTLE LABEL ART SHOWN BELOW

    ACNE 911 LABEL

  • INGREDIENTS AND APPEARANCE
    ADARA ACNE 911 DRYING 
    acne drying lotion suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-890
    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
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-890-0114 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/14/2023
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-890)
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