Label: PURE NERIUM ACNE THERAPY- salicylic acid 2.0% 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 October 3, 2019

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  • PURPOSE

    Acne Treatment Cream

  • ACTIVE INGREDIENT


    Salicylic acid 2.0%.

  • INDICATIONS & USAGE


    • For the treatment of acne.
    • Dries and clears acne blemishes, acne pimples, blackheads, whiteheads and allows skin to heal.
    • Penetrates pores to control acne blemishes, acne pimples, blackheads, whiteheads.
    • Helps keep skin clear of new acne blemishes, acne pimples, blackheads, whiteheads.

  • WARNINGS


    For external use only.​


    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.


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

  • INSTRUCTIONS FOR USE


    • Clean the skin thoroughly before applying this product.
    • 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 to three 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 a New User. Apply product sparingly to one or two small affected ares during the first 3 days. If no discomfort occurs, follow the directions stated above.

  • OTHER SAFETY INFORMATION


    Not recommended for use by pregnant or nursing women.

  • STORAGE AND HANDLING


    Transport and store in a cool dry place and keep away from direct sunlight.

  • INACTIVE INGREDIENT


    Aloe Barbadensis Leaf Juice, Nerium Oleander Leaf Extract (NAE8®), Water (Aqua), Propanediol, Hydrolyzed Egg Shell Membrane (Peptide Matrix – Collagen & Elastin), Cetyl Alcohol, Glycerin, Glyceryl Stearate, Potassium Cetyl Phosphate, Cetearyl Olivate, Caprylic/Capric Triglyceride, Dimethicone, Ricinus Communis (Castor) Seed Oil, Glyceryl Caprylate, Sorbitan Olivate, Lysolecithin, Sclerotium Gum, Xanthan Gum, Allantoin, Arginine, Avena Sativa Kernel Flour (Colloidal Oatmeal), Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Pelargonium Graveolens (Geranium) Flower Oil, Tocopherol, Fragrance, Leuconostoc/Radish Root Ferment Filtrate, Pullulan, Ocimum Basilicum (Basil) Extract, Linum Usitatissimum (Linseed) Seed Oil, Carum Petroselinum (Parsley) Extract, Benzyl Alcohol, Potassium Sorbate, Dipotassium Glycyrrhizate, Glyceryl Undecylenate, Sea Salt, Mahonia Aquifolium (Oregon Grape) Root Extract, Sodium Benzoate, Muriella Aurantiaca/Ruttnera Lamellosa Oil (Plankton Extract), Citric Acid, Lecithin

  • QUESTIONS


    1-(844)-599-7787 M-F (9 am to 5 pm CST)

  • DOSAGE & ADMINISTRATION

    2% Topical Cream

  • Principal Display Panel

    PURE
    NERIUM®

    ACNE
    THERAPY CREAM
    WITH SALICYLIC ACID

    PATENTED
    NERIUM ALOE
    EXTRACT

    NAE-8®

  • PURE NERIUM® -ACNE THERAPY CREAM, 30.3g/1.07 FL.OZ.

    30.3g/1.07FL.OZ.

  • INGREDIENTS AND APPEARANCE
    PURE NERIUM ACNE THERAPY 
    salicylic acid 2.0% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72216-227
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)  
    WATER (UNII: 059QF0KO0R)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OATMEAL (UNII: 8PI54V663Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EGG SHELL MEMBRANE (UNII: N7QBR4212V)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SEA SALT (UNII: 87GE52P74G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ARGININE (UNII: 94ZLA3W45F)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72216-227-321 in 1 CARTON09/16/2019
    1NDC:72216-227-1330.3 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/28/2019
    Labeler - Nerium SkinCare, Inc. (859420916)
    Registrant - Nerium SkinCare, Inc. (859420916)
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