Label: PURIFYING S.O.S SPOTGEL- salicylic acid, glycolic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 10, 2020

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  • ACTIVE INGREDIENT

    salicylic acid, glycolic acid

  • INACTIVE INGREDIENT

    water, glycerin, etc

  • PURPOSE

    a quick-fix spot treatment

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children

  • INDICATIONS & USAGE

    apply a small amount on affected areas with fingertips or cotton swap, day and night

  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PURIFYING S.O.S SPOTGEL 
    salicylic acid, glycolic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71217-0044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.04 g  in 100 mL
    GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71217-0044-110 mL in 1 TUBE; Type 0: Not a Combination Product01/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/26/2019
    Labeler - In This Morning (694519423)
    Registrant - In This Morning (694519423)
    Establishment
    NameAddressID/FEIBusiness Operations
    In This Morning694519423pack(71217-0044) , manufacture(71217-0044) , label(71217-0044)