Label: 3 IN 1 CLEANSER- salicylic acid liquid

  • 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 September 16, 2020

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  • Active Ingredients

    Salicylic Acid 1%

  • Purpose

    Salicylic Acid 1% ......Acne Treatment

  • Uses

    For the treatment of acne.

  • Warnings

    For External Use Only

    Keep out of Eyes

  • WHEN USING

    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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Wet face. Apply one to two pumps of foam onto wet skin. Gently massage in a circular motion. Rinse well.
    • 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 at room temperature.

  • Inactive Ingredients

    Water/Aqua/Eau, Decyl Glucoside, Diglycerin, Glycereth-26, PEG-6 Caprylic/Capric Glycerides, Kelp (Laminaria Digitata) Extract, Yeast (Saccharomyces Cerevisiae) Extract, Seaweed (Corallina Officinalis) Extract, Orchid (Orchis Morio) Flower Extract, Sodium Hyaluronate, Arginine, Dimethicone PEG-8 Meadowfoamate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Fragrance/Parfum, Hexylene Glycol, Urea*, Glucosamine HCl, Propylene Glycol. *Synthetic

  • PRINCIPAL DISPLAY PANEL

    PDP b

  • INGREDIENTS AND APPEARANCE
    3 IN 1 CLEANSER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72644-634
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ARGININE (UNII: 94ZLA3W45F)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    UREA (UNII: 8W8T17847W)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ANACAMPTIS MORIO FLOWER (UNII: PT2C4RA48D)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72644-634-0150 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/16/2020
    Labeler - SGII, INC. (070096792)
    Establishment
    NameAddressID/FEIBusiness Operations
    220 LABORATORIES INC783247950manufacture(72644-634)
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