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 January 8, 2018

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

  • Active ingredient

    salicylic acid 0.5%

  • Purpose

    Acne treatment

  • Uses

    For  the treatment oa acne

  • Warnings

    For external use only.

    Ask a doctor or pharmecist before use if you are using other topical acne medications at the same time or immediately following use of this product.


    When using this product

    skin irritaiton 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,rlush rhoroughly with water.

  • 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 te 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)

    store at room temperture.

  • INACTIVE INGREDIENT

    Water, salicylic acid,Cetearyl isononanoate,Ceteareth-20,fragrance,Cetearyl alcohol,Glyceryl stearate,glycerin,Ceteareth-12,Cetyl palmitate,Propylene glycol,methylparaben,Disodium EDTA,Propylparaben,2-bromo-2-nitropropane-1,3-diol

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE WIPES 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42255-603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    2-BROMO-2-NITROETHANOL (UNII: FA22WV2B2Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42255-603-0140 in 1 PACKAGE01/08/2018
    10.675 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:42255-603-0230 in 1 PACKAGE01/08/2018
    20.675 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/06/2015
    Labeler - ZHEJIANG GREENFACE HOUSEWARES CO., LTD. (546596567)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG GREENFACE HOUSEWARES CO., LTD.527999264manufacture(42255-603)