Label: BELLI ACNE CONTROL SPOT TREATMENT - sulfur cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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  • Belli Acne Control Spot Treatment
  • Active ingredient

    Colloidal Sulfur 3%

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  • Purpose

    Anti-Acne Agent

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  • Uses

    • reduces the severity of acne blemishes
    • helps prevent new acne blemishes
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  • 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 of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.

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  • When using this product

    • keep out of eyes
    • rinse with water to remove
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  • Stop use and ask a doctor if

    • rash or skin irritation develops
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  • Keep out of reach of children

    In case of accidental ingestion, contact a Poison Control Center immediately.

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  • Directions

    • cleanse the skin thoroughly before applying medication
    • 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 physician
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
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  • Other information

    • store below 77 degrees F / 25 degrees C
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  • Inactive ingredients

    Caprylyl Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Ethylhexylglycerin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Sorbate, Sodium PCA, Xanthan Gum

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  • Belli Acne Control Spot Treatment 14.75ml (42281-001-00)
  • INGREDIENTS AND APPEARANCE
    BELLI ACNE CONTROL SPOT TREATMENT  
    sulfur cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42281-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFUR (SULFUR) SULFUR 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CAPRYLYL GLYCOL  
    CHAMOMILE  
    CUCUMBER  
    WATER  
    ETHYLHEXYLGLYCERIN  
    RADISH  
    TEA TREE OIL  
    POTASSIUM SORBATE  
    SODIUM PYRROLIDONE CARBOXYLATE  
    XANTHAN GUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42281-001-00 1 in 1 CARTON
    1 14.75 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/02/2012
    Labeler - ABT Belli-Materna Inc (947134677)
    Registrant - ABT Belli-Materna Inc (947134677)
    Establishment
    Name Address ID/FEI Business Operations
    Chemolee Lab Corporation 809982754 manufacture(42281-001)
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