Label: RAF FIVE - WASH AWAY SALICYLIC ACID GEL CLEANSER- salicylic acid liquid

  • 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 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredients

    Salicylic acid 1.5%

  • 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

    • Wet face, then squeeze out a dime or quarter size amount and apply to face.
    • Use exfoliating brush in a gentle, circular motion around face and other areas with acne, avoiding eye area.
    • Rinse thoroughly with warm water.
  • Inactive ingredients

    Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, CocoGlucoside, Glycerin, Cocamidopropyl Hydroxysultaine, Cannabidiol, Niacinamide, Ergothioneine, PPG-12/SMDI Copolymer, Artemisia Vulgaris Oil, Juniperus Virginiana Oil, Mentha Citrata Leaf Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus, Glbulus Leaf Oil, Vitis Vinifera (Grape) Seed Oil, Mentha Viridis (Spearmint) Leaf Oil, Citrus Aurantium, Bergamia (Bergamot) Fruit Oil, Gluc- onolactone, Acrylates Crosspolymer-4, Tetrasodium Glutamate Diacetate, Polysorbate 20, Sodium Hydroxide, Sodium Chloride, Sodium Benzoate.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Tube Carton

    RAF™
    FIVE

    WASH
    AWAY

    GEL CLEANSER
    with CBD

    SALICYLIC ACID
    ACNE TREATMENT

    4 fl. oz. / 118 mL

    PRINCIPAL DISPLAY PANEL - 118 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    RAF FIVE - WASH AWAY SALICYLIC ACID GEL CLEANSER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4457
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Coco Glucoside (UNII: ICS790225B)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
    Cannabidiol (UNII: 19GBJ60SN5)  
    Niacinamide (UNII: 25X51I8RD4)  
    Ergothioneine (UNII: BDZ3DQM98W)  
    PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)  
    Artemisia Vulgaris Top Oil (UNII: 72Q967Y48V)  
    Juniperus Virginiana Oil (UNII: PAD4FN7P2G)  
    Lemon Oil, Cold Pressed (UNII: I9GRO824LL)  
    Eucalyptus Gum (UNII: 72T9EZC2VX)  
    Grape Seed Oil (UNII: 930MLC8XGG)  
    Spearmint Oil (UNII: C3M81465G5)  
    Bergamot Oil (UNII: 39W1PKE3JI)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-4457-1118 mL in 1 TUBE; 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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