Label: RAF FIVE - CLEAR THE WAY SALICYLIC ACID ACNE TREATMENT PADS- 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 26, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 1.5%

  • Purpose

    Acne treatment

  • Uses

    for the management of acne

  • Warning

    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.
    • Use the pads to cleanse skin or affected area as desired.
    • Wash hands after use.
    • 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, Niacinamide, Cannabidiol, Ergothioneine, PPG-12/SMDI Copolymer, Dipotassium Glycyrrhizate, Gluconolactone, Panthenol, 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, Polysorbate 20, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, 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 - 30 Pads Jar Carton

    RAF™
    FIVE

    CLEAR THE WAY

    SALICYLIC ACID
    ACNE TREATMENT PADS
    ALCOHOL FREE! with CBD

    30 PADS

    PRINCIPAL DISPLAY PANEL - 30 Pads Jar Carton
  • INGREDIENTS AND APPEARANCE
    RAF FIVE - CLEAR THE WAY SALICYLIC ACID ACNE TREATMENT PADS 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4456
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid1.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Propanediol (UNII: 5965N8W85T)  
    Niacinamide (UNII: 25X51I8RD4)  
    Cannabidiol (UNII: 19GBJ60SN5)  
    Ergothioneine (UNII: BDZ3DQM98W)  
    PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Panthenol (UNII: WV9CM0O67Z)  
    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)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-4456-130 in 1 JAR; 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!