Label: LET ME CLARIFY- salicylic acid gel

  • 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 30, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    SALICYLIC ACID 2%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USE FOR THE TREATMENT OF ACNE

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE * IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

  • ASK DOCTOR/PHARMACIST

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    • PREGNANT OR LACTATING.
    • YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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

    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

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

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • USE AM/PM. AFTER CLEANSING, GENTLY APPLY TO FACE OR AFFECTED AREAS.
    • BECAUSE EXCESSIVE DRYING OF THE FACE MAY OCCUR, START WITH ONE APPLICATION 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.
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    * AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER, BUTYLENE GLYCOL, GLYCOLIC ACID, POLYQUATERNIUM 10, EUCALYPTUS GLOBULUS OIL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ACETYL CARBOXYMETHYL COCOYL GLYCINE, MYRISTOYL TETRAPEPTIDE-13, HYDROXYPHENYL PROPAMIDOBENZOIC ACID, PENTYLENE GLYCOL, POTASSIUM HYDROXIDE.

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314 * WWW.LOVEMYBODY.COM

  • PRINCIPAL DISPLAY PANEL

    5-8 x 2_5ml Die-Line_LET ME CLARIFY_V3_10.24.11Let-Me-Clarify_Drug-Facts-Box

  • INGREDIENTS AND APPEARANCE
    LET ME CLARIFY 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ACETYL CARBOXYMETHYL COCOYL GLYCINE (UNII: 3TNX4P92J3)  
    MYRISTOYL TETRAPEPTIDE-4 (UNII: 87AV1IB2EU)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49520-103-1130 mL in 1 BOTTLE
    2NDC:49520-103-315 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/24/2012
    Labeler - mybody (004460532)
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