Label: ASD 3-IN-1- salicylic acid gel

  • 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 January 23, 2015

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

  • ACTIVE INGREDIENT

    Active Ingredient                                                    Purpose

    Salicylic Acid 2.0% .......................................... Acne Medication

  • PURPOSE

    Use

    for treatment of acne

  • 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.

  • INDICATIONS & USAGE

    Developed by Swedish plastic surgeons and skin care specialists

    Cicamed ASD 3-in-1

    salicylic acid 2% acne medication

    Acne Treatment

    • Helps deemphasize appearance of skin discoloration and scars
    • Triple-active formula for treatment of acne

    #1 choice of plastic surgeons and dermatologists in Sweden

    Made in Sweden

    Net Wt 0.5 oz. (15g)

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times 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
  • WARNINGS

    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 irritations occurs, only use one topical acne medication at a time.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, alcohol denat., zinc oxide, capylic/capric trigylceride, dimethicone, glycerin, jojoba (simmondsia chinensis) seed oil, niacinamide, olivoyl hydrolyzed wheat protein, glycolic acid, glyceryl laurate, octoxyglycerin, allantoin, aloe barbadensis leaf juice, panthenol, witch hazel (hamamelis virginiana) leaf extract, tocopherol, retinyl palmitate, xanthan gum, sodium phytate, cetearyl alcohol, glyceryl oleate, glyceryl stearate, squalane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 60, potassium hydroxide, sodium benzoate, potassium sorbate

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ASD 3-IN-1 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69541-001
    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
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SQUALANE (UNII: GW89575KF9)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69541-001-0115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/23/2015
    Labeler - Almen Cosmetic Group AB (775651271)
    Establishment
    NameAddressID/FEIBusiness Operations
    Almen Cosmetic Group AB775651271manufacture(69541-001)