Label: EPHIDERM SPOT TREATMENT- salicylic acid lotion

  • 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 April 4, 2013

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  • Active Ingredient:

    Salicylic acid 1.0%

  • PURPOSE

  • Uses:

    Treats and helps prevent acne blemishes

  • Warnings:

    For external use only. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Using other topical acne medications at the same time or right after use of this product may increase skin dryness or irritation. Avoid doing this, unless directed by a doctor. Avoid unnecessary sun exposure and use sunscreen. Allow epHiderm Spot Treatment to dry, then follow the sunscreen directions. Do not use this product if you have sensitive skin or if you are sensitive to AHAs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use this product on infants under 6 months of age.

  • Directions:

    Apply a thin layer to the affected area, In the morning and evening. For best results, apply epHiderm Synergyzer after epHiderm Spot Treatment. Wash hands thoroughly after application.

  • Inactive Ingredients:

    Water, Isopropyl alcohol, Propylene glycol, Hydroxyethylcellulose, Mandelic acid, Methyloxirane, Oxirane, Sodium benzoate, FD&C Blue #1

    Distributed by: Kantian Skincare, LLC.
    Smithtown, NY, 11787. Made in USA ©2012.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    epHiderm

    ANTI-ACNE SOLUTION
    SPOT TREATMENT

    Eliminates acne causing bacteria
    Clears acne pimples and blackheads quickly
    Gentle enough for everyday use

    Dermatologist Recommended

    MADE IN USA

    NET WT. 1 OZ (28g)

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    EPHIDERM SPOT TREATMENT 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57524-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    Mandelic Acid (UNII: NH496X0UJX)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Propylene Oxide (UNII: Y4Y7NYD4BK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57524-013-0128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B01/10/2013
    Labeler - KANTIAN SKINCARE, LLC (078436984)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kantian Skincare, LLC078436984LABEL(57524-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc010297942MANUFACTURE(57524-013)
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