Label: ACNE CLEANSING PADS- salicylic acid liquid

  • 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 June 17, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 2%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USE

    FOR THE TREATMENT OF ACNE

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER
    • KEEP AWAY FROM LIPS AND MOUTH.
  • DO NOT USE

    DO NOT USE THIS MEDICATION IF YOU HAVE VERY SENSITIVE SKIN.

  • ASK DOCTOR/PHARMACIST

    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.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • GENTLY WIPE THE ENTIRE AFFECTED AREA WITH A PAD ONE TO THREE TIMES DAILY.
    • DO NOT RINSE.
    • BECAUSE EXCESSIVE DRYING OF THE SKIN CAN OCCUR, START WITH ONE APPLICATION DAILY, THENGRADUALLY INCREASE TO TWO TO THREE TIMES DAILY IF NEEDED AS DIRECTED BY A DOCTOR.
    • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    ALOE BARBADENSIS LEAF EXTRACT (ALOE EXTRACT), CAPRYLYL GLYCOL, CITRIC ACID, DISODIUM EDTA, FRAGRANCE, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, LAURYL GLUCOSIDE, MENTHOL, PHENOXYETHANOL, PPG-5-CETETH-20, SIMETHICNE, SODIUM BORATE, SODIUM CITRATE, SODIUM LAURYL GLUCOSE CARBOXYLATE, WATER

  • QUESTIONS

    QUESTIONS OR COMMENTS? 1-877-445-4624

  • PRINCIPAL DISPLAY PANEL

    DLSC_CleansingPads_Label

  • INGREDIENTS AND APPEARANCE
    ACNE CLEANSING PADS 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58876-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58876-102-2770 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/13/2013
    Labeler - DR LIN SKINCARE (622329980)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIAMOND WIPES INTERNATIONAL, INC.161104729manufacture(58876-102) , pack(58876-102)
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