Label: ANNA GUANCHE MD MIRACLE CREAM THE PIMPLE CREAM- sulfur cream

  • NDC Code(s): 80841-100-01
  • Packager: Bella Cosmeceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Sulfur 10%

  • PURPOSE

    Purpose

    Acne Treatment

  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product

    • 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.
    • avoid contact with eyes. If contact occurs, flush thoroughly with water.
    • apply only to areas with acne.
  • STOP USE

    Stop use and ask a doctor if skin irritation or redness develops.

  • 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.

  • INDICATIONS & USAGE

    Uses

    • For Treatment of acne
  • DOSAGE & ADMINISTRATION

    Directions

    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to two times daily
    • because excessive drying of the skin may occur, start with one application daily then gradually increase to two 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
    • Sensitivity Test for New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomforts occurs, follow directions stated above.
  • STORAGE AND HANDLING

    Other information Store at 68°F- 77°F (20°C- 25°C).

  • INACTIVE INGREDIENT

    Inactive ingredients Water ( Aqua), Helianthus Annuus (Sunflower) Seed Oil, Dicaprylyl Carbonate, Acacia Senegal Gum, Squalane, Glycerin, Calamine, Shea Butter, Glycerides, Dimethicone, Cetearyl Alcohol, Glyceryl Stearate, PEG-100, Stearane, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Bisabolol, Tocopheryl Acetate, Magnolia Officinalis Bark Extract, Hydroxyphenyl Propamidobenzoic Acid, Stearic Acid, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Pentylene Glycol, Disodium EDTA, Butylene Glycol, Caprylyl Glycol, Penoxyethanol, Fragrance (Parfum)

  • DO NOT USE

    Do not use on

    • broken skin
    • large areas of the skin
  • QUESTIONS

    Call 818-324-4339 or visit www.miraclecreambybella.com

  • PRINCIPAL DISPLAY PANEL

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    MCIP1

  • INGREDIENTS AND APPEARANCE
    ANNA GUANCHE MD MIRACLE CREAM THE PIMPLE CREAM 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80841-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80841-100-0129.5 mL in 1 JAR; Type 0: Not a Combination Product11/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/17/2020
    Labeler - Bella Cosmeceuticals, Inc. (117691855)
    Registrant - KDC/ONE SOCAL LABORATORIES, LLC (118384240)
    Establishment
    NameAddressID/FEIBusiness Operations
    KDC/ONE SOCAL LABORATORIES, LLC118384240manufacture(80841-100)