Label: ACNE SPOT TREATMENT- salicylic acid gel

  • NDC Code(s): 70764-105-11, 70764-105-51
  • 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 EXFOLIATING GEL THAT AIDS IN REDUCING ACNE BREAKOUTS.

  • WARNINGS

    FOR EXTERNAL USE ONLY. DO NOT USE ON BROKEN SKIN. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

  • DIRECTIONS

    APPLY A SMALL AMOUNT WITH FINGERS TO CLEAN, DRY SKIN. MAY BE USED ALL OVER THE AFFECTED AREA OR USED TO SPOT TREAT BLEMISHES. IF ANY DISCOMFORT OCCURS, REDUCE FREQUENCY OR DISCONTINUE USE.

  • INACTIVE INGREDIENTS

    WATER, GLYCOLIC ACID (3%), SD ALCOHOL 40-A, ALOE BARBADENSIS LEAF JUICE, WITCH HAZEL, GLYCERIN, TRIETHANOLAMINE, METHYL GLUCETH-20, SODIUM LACTATE, FRUCTOSE, UREA, NIACINAMIDE, INOSITOL, SODIUM BENZOATE, LACTIC ACID, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL, PANTHENOL, ALLANTOIN, GLUCOSAMINE SULFATE, METHYLISOTHIAZOLINONE.

  • 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.

  • DO NOT USE

    DO NOT USE IF ALLERGIC TO ASPERIN.

  • QUESTIONS OR COMMENTS:

    WWW.CONTROLCORRECTIVE.COM

    TOLL FREE 1-866-290-4290  

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    01b UC_Acne Spot Treatment

  • INGREDIENTS AND APPEARANCE
    ACNE SPOT TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70764-105
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    UREA (UNII: 8W8T17847W)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    INOSITOL (UNII: 4L6452S749)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70764-105-511 in 1 BOX06/09/2016
    1NDC:70764-105-1130 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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