Label: ROSEMARY AND SALICYLIC ACID ACNE CLEARING MOISTURIZER- salicylic acid 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 December 1, 2021

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Use

    For treatment of acne

  • Warning

    For external use only

    Ask a doctor or pharmacist before use if you are using other topical acne products at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Stop Use and Ask a Doctor if redness or irritation occurs. Avoid contact with eyes.

    When using this product, avoid contact with eyes. If contact occurs, flush thoroughly with water. If your skin will be exposed to the sun after use, apply a sunscreen with an SPF of 30 or greater.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Cleanse skin thoroughly before applying a generous amount to the face.
    • Avoid contact with eyes.
    • Can be used morning or night.
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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.
  • Questions or Comments?

    call toll free 646-979-3997

  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, Glyceryl Stearate, Coconut Alkanes, Cetyl Alcohol, Glycerin, Stearic Acid, Glyceryl Stearate Citrate, Stearyl Alcohol, 1,2-Hexanediol, Xantham Gum, Cydonia Oblonga Leaf Extract, Citric Acid, Caprylyl Glycol, Maltodextrin, Bixa Orellana Seed Extract, Citrus Limon (Lemon) Peel Oil, Tocopherol, Spiraea Ulmaria (Meadowsweet) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Citrus Medica Limonum (Lemon) Peel Extract, Sodium Hyaluronate

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Naturopathica Holistic Health
    New York, NY 10001.

  • PRINCIPAL DISPLAY PANEL - 50 ML Jar Carton

    NATUROPATHICA®
    FOR DEEPER BEAUTY

    ROSEMARY &
    SALICYLIC ACID

    ACNE CLEARING
    MOISTURIZER

    1.7 FL OZ / 50 ML

    PRINCIPAL DISPLAY PANEL - 50 ML Jar Carton
  • INGREDIENTS AND APPEARANCE
    ROSEMARY AND SALICYLIC ACID ACNE CLEARING MOISTURIZER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64657-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CYDONIA OBLONGA LEAF (UNII: 2184487NM7)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    ROSEMARY (UNII: IJ67X351P9)  
    LEMON PEEL (UNII: 72O054U628)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64657-004-041 in 1 CARTON10/25/2021
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/25/2021
    Labeler - Naturopathica Holistic Health (104302175)
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