Label: SOOTHION PSORIASIS AND SEBORRHEIC DERMATITIS FORMULA- 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 December 23, 2019

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

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Psoriasis / Seborrheic Dermatitis

  • Uses

    Controls and helps eliminate recurrence of:
    • skin itching
    • irritation
    • redness
    • flaking and scaling associated with psoriasis and seborrheic dermatitis.
  • Warnings

    For external use only.

    Ask a doctor before use

    • if condition covers a large area of the body.

    When using this product

    • avoid contact with the eyes. If contact occurs rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use of this product as directed.

    If pregnant or breast feeding ask a doctor before use.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

  • Directions

    • apply to affected areas one to four times daily or as directed by a doctor.
  • Other information

    • Store in a cool, dry place below 77°F
    • Protect from heat and light


  • Inactive ingredients

    arnica montana flower, calendula officinalis flower, cannabis sativa seed oil, emulsifying wax, horse chestnut, imidazolidinyl urea, sheanut oil, spearmint oil, stearic acid, water

  • DESCRIPTION


    Manufactured for Electrolyzed Innovations, LLC
    (866) 528-3721   2214 Wilshire Dr, Piqua, OH 45356 USA
  • Principal Display Panel


    Psoriasis and Seborrheic Dermatitis Formula

    Soothion

    Ion Dispersion Formula Designed to Relieve

    • Itching
    • Redness
    • Irritation
    • Flaking
    • Scaling


    Net Wt. 8 oz ( 226 g )                  Made in USA

    Soothion Psoriasis Label

  • INGREDIENTS AND APPEARANCE
    SOOTHION PSORIASIS AND SEBORRHEIC DERMATITIS FORMULA 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69031-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    IMIDUREA (UNII: M629807ATL)  
    SHEANUT OIL (UNII: O88E196QRF)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69031-004-08226 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/01/2015
    Labeler - Electrolyzed Innovations, LLC (079168827)
    Establishment
    NameAddressID/FEIBusiness Operations
    TropiChem Research Labs, Inc.603123068manufacture(69031-004)