Label: ASSURED ACNE CREAM- acne cream cream

  • 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 15, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredient


    Salicylic Acid  0.5%
  • Purpose


    Acne Treatment

  • Warnings

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally

    Ask a doctor before use if you have deep puncture wounds or serious burns

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area

    Stop use and ask a doctor if condition persists or gets worse.

    Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

  • Use

    for the treatment of acne.

  • WARNINGS

    For external use only.

    Do not use if you have very sensitive skin or are sensitive to Salicylic Acid.

    Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    When using this product, avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

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

  • Directions

    Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. 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 occurs, reduce application to once a day.

  • Other information

    store between 20 to 25 C (66 to 77 F)

  • Inactive ingredients

    carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water.

  • Package Label

    Acne CreamEnter section text here

  • INGREDIENTS AND APPEARANCE
    ASSURED ACNE CREAM 
    acne cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35038-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 74.5 mL  in 100 mL
    SQUALANE (UNII: GW89575KF9) 10 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 5 mL  in 100 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 3.5 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    GLYCOL STEARATE (UNII: 0324G66D0E) 2 mL  in 100 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) 1 mL  in 100 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) .2 mL  in 100 mL
    PROPYLPARABEN (UNII: Z8IX2SC1OH) .1 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) .1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35038-200-0144 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2010
    Labeler - HANGZHOU MINO DAILY CHEMICALS CO.LTD. (527974203)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU MINO DAILY CHEMICALS CO.LTD.527974203manufacture
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