Label: SOOTHION ACNE TREATMENT 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

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  • Active ingredient

    Salicylic acid 1%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of Acne.
    • Clears up acne pimples, blackheads and whiteheads 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.

    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 right away.
  • Directions

    • clean the skin thoroughly before applying this product.
    • cover the entire affected area with a thin layer one to three times a 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, dry place below 77°F
    • Protect from heat and light


  • Inactive ingredients

    melaleuca alternifolia leaf, polyacrylic acid, water

  • DESCRIPTION

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

    Ion Infused

    Acne Treatment Formula

    Soothion

    Ion Disperson Formula Designed to Clear Up

    • Acne
    • Pimples
    • Blemishes
    • Whiteheads
    • Blackheads

    Net Wt. 8 oz (240 mL)              Made in USA

    Soothion Acne Label


  • INGREDIENTS AND APPEARANCE
    SOOTHION ACNE TREATMENT FORMULA 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69031-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69031-005-08226 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 finalpart333D04/01/2015
    Labeler - Electrolyzed Innovations, LLC (079168827)
    Establishment
    NameAddressID/FEIBusiness Operations
    TropiChem Research Labs, Inc.603123068manufacture(69031-005)
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