Label: EXFO TONIC ACNE TREATMENT- salicylic acid solution

  • NDC Code(s): 70764-104-11, 70764-104-51
  • Packager: CONTROL CORRECTIVE SKINCARE INC
  • 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 22, 2023

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  • ACTIVE INGREDIENTS

    SALICYLIC ACID (2.0%)

  • PURPOSE

    ACNE TREATMENT

  • USE

    AN ANTISEPTIC AND EXFOLIATING TONIC DESIGNED TO CONTROL EXCESSIVE OILINESS, REDUCE BREAKOUTS AND DISOLVE DEAD CELL BUILD UP.

  • WARNINGS

    MAY TINGLE WHEN FIRST APPLIED. FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. AVOID UNNECESSARY SUN EXPOSURE AS THIS PRODUCT MAY INCREASE YOUR SENSITIVITY TO THE SUN. DISCONTINUE USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS.

  • DIRECTIONS

    APPLY OR SPRAY ONTO TISSUE OR COTTON PAD, THEN APPLY TO ENTIRE FACE OR JUST THE ACNE-PRONE AREAS AS NEEDED. MAY BE APPLIED ONCE OR TWICE DAILY.

  • INACTIVE INGREDIENTS

    WATER, GLYCOLIC ACID (3%), SD ALCOHOL 40-A, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, PEG-40 HYDROGENATED CASTOR OIL.

  • 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.

  • QUESTIONS OR COMMENTS

    WWW.CONTROLCORRECTIVE.COM

    TOLL FREE 1-866-290-4290  

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Box_Exfo Tonic 6.7oz OL

  • INGREDIENTS AND APPEARANCE
    EXFO TONIC ACNE TREATMENT 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70764-104
    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)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ALCOHOL (UNII: 3K9958V90M)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70764-104-511 in 1 BOX06/09/2016
    1NDC:70764-104-11198 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/09/2016
    Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)
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