Label: RAF FIVE - SPOT ON SALICYLIC ACID ROLL-ON ACNE TREATMENT- 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 August 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2.0%

  • Purpose

    Acne treatment

  • Uses

    for the management of acne.

  • Warnings

    For external use only

    When using this product

    • Skin irritation and dryness are 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.
    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor.

    • If irritation becomes severe.

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

  • Directions

    • Cleanse the skin thoroughly before applying this product.
    • Roll on to 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 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.
  • Inactive Ingredients

    Water (Aqua), Pentylene Glycol, Propanediol, PPG -12 /SMDI Copolymer, Niacinamide, Cetearyl Olivate,Ethoxydiglycol, Sorbitan Olivate, Cetearyl Alcohol Cannabidiol, Dipotassium Glycyrrhizate, Ergothioneine, Artemisia Vulgaris Oil Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Mentha Citrata Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Vitis Vinifera (Grape) Seed Oil, Amylopectin Dextrin, Polydextrose, Hydroxyethylcellulose, Glyceryl Caprylate, Sclerotium Gum, Caprylhydroxamic Acid, Caprylyl Glycol.

  • SPL UNCLASSIFIED SECTION

    Distributed by
    ILERA DERM LLC,
    a subsidiary of
    Zelira Therapeutics LTD.
    5110 Campus Drive
    Plymouth Meeting,
    PA 19462

  • PRINCIPAL DISPLAY PANEL - 15 g Bottle Carton

    RAF™
    FIVE

    SPOT ON

    SALICYLIC ACID
    ROLL-ON
    ACNE TREATMENT
    with CBD

    Net Wt.
    0.5oz. / 15g

    PRINCIPAL DISPLAY PANEL - 15 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    RAF FIVE - SPOT ON SALICYLIC ACID ROLL-ON ACNE TREATMENT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4455
    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
    Water (UNII: 059QF0KO0R)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Propanediol (UNII: 5965N8W85T)  
    PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)  
    Niacinamide (UNII: 25X51I8RD4)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cannabidiol (UNII: 19GBJ60SN5)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Ergothioneine (UNII: BDZ3DQM98W)  
    Artemisia Vulgaris Top Oil (UNII: 72Q967Y48V)  
    Bergamot Oil (UNII: 39W1PKE3JI)  
    Lemon Oil, Cold Pressed (UNII: I9GRO824LL)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Juniperus Virginiana Oil (UNII: PAD4FN7P2G)  
    Spearmint Oil (UNII: C3M81465G5)  
    Grape Seed Oil (UNII: 930MLC8XGG)  
    Polydextrose (UNII: VH2XOU12IE)  
    Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
    Glyceryl Monocaprylate (UNII: TM2TZD4G4A)  
    Betasizofiran (UNII: 2X51AD1X3T)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-4455-115 g in 1 BOTTLE; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/01/2021
    Labeler - Cosmetic Solutions LLC (807907928)
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