Label: RAEL BEAUTY MIRACLE CLEAR COMPLETE ACNE SERUM- salicylic acid emulsion

  • 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 June 9, 2023

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  • Drug Facts

  • Active ingredients

    Salicylic Acid 1.5%

  • Purpose

    Acne treatment

  • Uses

    • for the treatment of acne
    • reduces the number of acne blemishes and allows skin to heal
  • 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.

    Keep out of reach of children.

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

  • Directions

    • 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 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
  • Other information

    • store in a cool, dark place
  • Inactive ingredients

    Water, Propanediol, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Niacinamide, Sodium Citrate, Avena Sativa (Oat) Kernel Flour, C13-15 Alkane, Panthenol, Gluconolactone, Silica, Lysolecithin, Sclerotium Gum, Cellulose, Zinc PCA, Capryloyl Salicylic Acid, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Pullulan, Xanthan Gum, Sodium Hyaluronate, Sodium Phytate, Succinic Acid, Potassium Hydroxide, Calcium Gluconate, Centella Asiatica Extract

  • Questions or comments?

    (800) 573-1516

  • Company Information

    Manufactured for Rael, Inc. Los Angeles, CA 90012

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    RAEL BEAUTY MIRACLE CLEAR COMPLETE ACNE SERUM 
    salicylic acid emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72863-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    OATMEAL (UNII: 8PI54V663Y)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72863-109-011 in 1 CARTON01/01/2024
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00601/01/2024
    Labeler - Rael, Inc. (087378348)
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