Label: CLASSIC CARE APRICOT SCRUB BLEMISH CONTROL- salicylic acid cream

  • 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 March 28, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Salicylic Acid (2%)

  • Purpose

    Acne Treatment

  • Use

    Treats Acne

  • Warnings

    For external use only.

    When using this product, skin irritation 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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Moisten face with water. Dispense product onto fingertips and massage over face. Rinse with water. Avoid direct contact with eyes. In case of contact with eyes, flush thoroughly with water. For best results use 3 to 4 times per week.

  • Inactive Ingredients

    Water, Apricot Shell Powder, Sodium Lauryl Ether Sulfate, Light Liquid Paraffin, Glycerin, Cetyl Alcohol, Stearic Acid, Cetosteryl Alcohol, Glyceryl Mono Stearate, Triethanolamine, Carbomer,Perfume, Titanium dioxide, Methyl Isothiazolinone.

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    FDN Enterprises, LLC.
    Opa Locka, FL 33054

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Label

    FOR SENSITIVE SKIN

    Classic Care®

    APRICOT SCRUB

    BLEMISH CONTROL
    for clean & clear skin

    NET WT. 6 OZ

    100%
    ♦   NATURAL EXFOLIANTS
    ♦   PARABEN FREE

    PRINCIPAL DISPLAY PANEL - 170 g Tube Label
  • INGREDIENTS AND APPEARANCE
    CLASSIC CARE APRICOT SCRUB   BLEMISH CONTROL
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Light Mineral Oil (UNII: N6K5787QVP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Trolamine (UNII: 9O3K93S3TK)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60691-124-32170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D09/26/2012
    Labeler - FDN Enterprises, LLC (965743867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vikshara Trading & Investments Ltd675920690MANUFACTURE(60691-124)
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