Label: ACNE CLARIFYING CREAM- salicylic acid cream

  • 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 December 4, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Salicylic Acid 2%

  • PURPOSE

    Acne Treatment Cream

  • INDICATIONS & USAGE

    Uses: Treats Acne, dries up Acne, helps prevent new acne

  • WARNINGS

    For external use only

  • DO NOT USE

    do not use:

    on a broken skin

    if pregnant or lactating

  • WHEN USING

    when using this product:

    avoid unnecessary sun exposure and use a sunscreen

    do not use in or near the eyes

    using other acne topical drugs at the same time or right after use of this product may increase dryness or irritation of the skin

  • STOP USE

    stop use and ask a doctor if too much irritation or sensitivity developes or increases

  • KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions: Cleanse the skin thoroughly, then apply a hydration serum before applying the acne clarifying cream. Cover the affected and surrounding area with a thin layer. Avoid eye area. For evening or night use only

  • OTHER SAFETY INFORMATION

    Store at 20-25 C (68-77 F)

  • INACTIVE INGREDIENT

    Water (Aqua), Glycolic Acid, Caprylic/Capric triglyceride, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol and Dicetyl Phospahte, Ceteth 10 Phosphate, Azelaic Acid, Glycerin, Hexyl Laurate, Lactic Acid, Sorbitol, Ammonium Hydroxide, Butylene Glycol, Cetyl Alcohol, PPG-12/SMDI Copolymer, Sodium Hyaluronate, Yeast (Faex) Extract, Propylene Glycol, Symphytum Officinale Extract, Plantago Ovata Seed Extract, Amino Acids, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Stearic Acid, Tocopheryl Acetate, Dimethicone, Imperata Cylindrica Root Extract, Hydrolyzed Wheat Protein, Hydrolyzed Wheat Starch, Butyrospermum Parkii (Shea Butter), Mangifera Indica (Mango) Seed Butter, Xanthan Gum, Magnisium Aluminium Sulphate, Glycine, Lavandula Angustifolia (Lavender)Oil, Ceramides, Disodium EDTA   

  • PRINCIPAL DISPLAY PANEL

    Physicians Aesthetic Research, Inc., Distr.

    San Clemente, CA 92672

    Made in U.S.A.

    www.lucrece.com

    Acne Clar Cream 20

  • INGREDIENTS AND APPEARANCE
    ACNE CLARIFYING CREAM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SORBITOL (UNII: 506T60A25R)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    YEAST (UNII: 3NY3SM6B8U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
    PLANTAGO OVATA SEED (UNII: UD50RBY30F)  
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCINE (UNII: TE7660XO1C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4113-159 mL in 1 TUBE; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/04/2017
    Labeler - Allure Labs, Inc (926831603)