Label: ALBA BOTANICA FAST FIX FOR PIMPLE- sulfur cream

  • 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 February 5, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sulfur 6.0%

  • DOSAGE & ADMINISTRATION

    Using finger, dab tiny amount on blemishand gently tap to cover with thin layer. For more coverage allow to dry and repeat. Use alone, over or under makeup.

  • PURPOSE

    Acne Treatment

  • WARNINGS

    For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

  • INACTIVE INGREDIENT

    Water, Isoamyl Laurate, Caprylic/Capric Triglyceride, Titanium Dioxide (CI77891), Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Salix Alba (Willow) Bark Extract (1), Alcohol (1), Alumina, Stearyl Alcohol, Cetyl Alcohol, Citric Acid, Glycerin, Jojoba Ester, Saccharomyces Ferment, Silica, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI77491).

    (1) Certified Organicf Ingredient;

  • INDICATIONS & USAGE

    For the treatment of acne.

  • PRINCIPAL DISPLAY PANEL

    FB label

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA FAST FIX FOR PIMPLE 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2796
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2796-130 g in 1 PACKET; Type 0: Not a Combination Product01/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/21/2016
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-2796)
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