Label: ACNE- salicylic acid 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 July 21, 2014

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  • DRUG FACTS

  • Active ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Uses

    for the treatment of acne

  • WARNINGS

    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.

    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 dryness or peeling occurs, reduce application to once a day.

  • Other information

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

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Acne Cream LabelEnter section text here

  • INGREDIENTS AND APPEARANCE
    ACNE 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) 2 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1307-11 in 1 BOX
    143 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/2013
    Labeler - GREENBRIER INTERNATIONAL INC (610322518)
    Registrant - HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED (547695235)
    Establishment
    NameAddressID/FEIBusiness Operations
    HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED547695235manufacture(33992-1307)
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