Label: ACNE LOTIONSULFUR SULFUR- sulfur lotion

  • Category: HUMAN OTC DRUG LABEL

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 June 10, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Sulfur - 3%

  • PURPOSE

    Purpose: Acne Treatment

  • INDICATIONS & USAGE

    Uses: For the treatment of acne

  • WARNINGS

    Warning:

    • For external use only
    • Avoid contact with eyes, if product get into eyes, rinse thoroughly with water.
    • If excessive irritation develops or increases discontinue use and consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of the reach of children

  • DOSAGE & ADMINISTRATION

    Directions:

    • After cleansing and toning apply lotion over the entire face.
    • Use daily.
    • If going outside use a sunscreen.
    • Allow Clearogen to dry then follow directions in the sunscreen labeling.
    • If irritation or sensitivity develops, discontinue use of all products and consult a doctor.
  • INACTIVE INGREDIENT

    Aqua, Lenolenic Acid, Lenoleic Acid, Glycerine, Soybeen, PEG-6 Caprylic/Capric glycerides, Cetostearyl  acohol, Dihexadecyl phosphate, Ceteth-10 phosphate, Dimethicone, Dodecyl gallate, Ethylhexyl gallate, Saw palmetto, Glyceryl monostearate, PEG-100 stearate, Cetyl alcohol, Polyacrylamide, C13- 14 Isoparaffin, Laureth-7, Aloe vera leaf, Phenoxyethanol, Calrylyl Glycol, Ethylhexyl glycerin, Hexylene glycol, Stearic acid, Propylene glycol, Comfrey leaf, Plantago ovata seed, Glutamine, Proline, Leucine, Serine, Trolamine, Green tea leaf, Azadirachta indica leaf, Chamomile, Levender oil, Xantham gum, Alpha-tocopherol acetate, Malva sylvestris extract, Melissa officinalis leaf, Achillea Millefolium, Sodium hyaluronate, Imperata Cylendrica root, Edetate disodium, Magnesium aluminum silicate.

  • PRINCIPAL DISPLAY PANEL

    Advanced Skin & Hair

    Los Angeles, California 90025

    877-30-CLEAR

    clearogen.com

    Made In USA

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE LOTIONSULFUR   SULFUR
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4072
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DODECYL GALLATE (UNII: 45612DY463)  
    ETHYLHEXYL GALLATE (UNII: O14R793D1H)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    PLANTAGO OVATA SEED (UNII: UD50RBY30F)  
    GLUTAMINE (UNII: 0RH81L854J)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    LEUCINE (UNII: GMW67QNF9C)  
    SERINE (UNII: 452VLY9402)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    PRIMULA VERIS (UNII: W6LFQ57E4M)  
    ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4072-155 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/10/2014
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4072)
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