Label: PHACE BIOACTIVE CLARIFYING SERUM- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

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 October 9, 2019

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  • Drug Facts

  • Active ingredients

    Salicylic Acid 1.5%

    Purpose

    Acne Treatment

  • Uses

    • for the treatment of acne
    • reduces the number and severity 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. Avoid eye contact. If contact occurs, flush thoroughly with water.

    Keep out of reach of children.

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

  • Directions

    • after cleansing, apply a thin layer to affected area 1-3 times daily. If irritating dryness or peeling occurs, reduce application to once per day or every other day.
  • Inactive Ingredients

    Aqua/Water/Eau, Arnica Montana Flower Extract, Capryloyl Salicylic Acid, Centella Asiatica Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Diisopropyl Adipate, Glycolic Acid, Hydroxyethylcellulose, Hydroxyethylpiperazine Ethane Sulfonic Acid, Methylisothizolinone, Octadedecenedioic Acid, Polysorbate 80, Alcohol Denat., Sodium Hydroxide, Propanediol, Zingiber Officinale (Ginger) Extract.

  • Other Information

    Store in a cool, dark place.

  • Questions or comments?

    Toll-free 1-800-942-1498 or visit www.phacebioactive.com

  • Package Labeling:

    ClarifyingSerumLabel

  • INGREDIENTS AND APPEARANCE
    PHACE BIOACTIVE CLARIFYING SERUM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-683
    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
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CUCUMBER (UNII: YY7C30VXJT)  
    TURMERIC (UNII: 856YO1Z64F)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-683-011 in 1 CARTON02/10/2017
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/13/2016
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-683)