Label: ACNE WIPES- salicylic acid swab

  • 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 29, 2015

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  • Active ingredient

    Sallcylic Acid 0.5%

  • Purpose

    acne treatment

  • Use

    for the treatment of acne.

  • Warnings

    for external use only

    ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately

    over large areas of the body following use of this product.

    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.

    avoid contact with eyes,if contact occurs ,flush thoroughly with water.

  • Keep out of reach of children .if swallowed,get medical help or contact a Poison Control Center reght away.

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

  • Directions

    use daily to get clear skin.

    clean the skin thoroughly before applying this product.

    cover the entire affected area 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.

    throw away cloth(do not flush)

  • INACTIVE INGREDIENT

    water ,cetearyl isononaneate,ceteareth-20,fregrance,cetearyl alcohol,glyceryl stearate,glycerin,ceteareth-12,cetyl palmitate,proplyene glycol,methjylparaben,disodium EDTA,propylparaben,2-bromo-2-nitropropane-1,3-Diol

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ACNE WIPES 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69733-566
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69733-566-0830 in 1 PACKAGE
    10.623 mg in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/30/2015
    Labeler - JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD (421340473)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD421340473manufacture(69733-566)