Label: ACNE SOLUTIONS- 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 September 29, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Uses

    • treats acne
    • clears acne blemishes
    • helps prevent development of new acne blemishes
  • Warnings

    For external use only.

    When using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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

  • Directions

    • pump dispenser 2-3 times
    • massage gently over wet skin, avoiding eye area
    • rinse
    • use AM and PM
    • if bothersome drying or peeling occurs, reduce usage to every other day
    • after acne clears, continue using for preventative care
    • follow with Acne Solutions Clarifying Lotion
  • Inactive ingredients

    water, glycerin • butylene glycol • sodium methyl cocoyl taurate • sucrose • disodium phosphate • arginine cocoate • laminaria saccharina extract• cola nitida (kola) seed extract • caffeine • algae extract • mentha piperita (peppermint) • sea whip extract • peg/ppg-18/18 dimethicone • sodium hyaluronate • ppg-6 decyltetradeceth-30 • lactobacillus ferment • stearamidopropyl dimethylamine • longifolene • acetyl glucosamine • capryloyl glycine • perilla aldehyde • 10-hydroxydecanoic acid • polyquaternium-7 • beta-caryophyllene • phospholipids • sodium stearate • sodium salicylate • disodium edta • phenoxyethanol • chloroxylenol [iln32337]

  • SPL UNCLASSIFIED SECTION

    © CLINIQUE LABORATORIES, DIST. N.Y., N.Y. 10022

  • PRINCIPAL DISPLAY PANEL - 125 ml Bottle Label

    C
    CLINIQUE
    acne solutions

    cleansing foam

    STEP 1
    SALICYLIC ACID ACNE MEDICATION

    4.2 FL.OZ./125 ml e

    Principal Display Panel - 125 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS   CLEANSING FOAM
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-992
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    butylene glycol (UNII: 3XUS85K0RA)  
    sodium methyl cocoyl taurate (UNII: JVL98CG53G)  
    sucrose (UNII: C151H8M554)  
    saccharina latissima thallus (UNII: 68CMP2MB55)  
    cola nut (UNII: PQM9SA369U)  
    caffeine (UNII: 3G6A5W338E)  
    peppermint (UNII: V95R5KMY2B)  
    pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    stearamidopropyl dimethylamine (UNII: K7VEI00UFR)  
    N-acetylglucosamine (UNII: V956696549)  
    capryloyl glycine (UNII: 8TY5YO42NJ)  
    perillaldehyde (UNII: 6EQL0XA86G)  
    10-hydroxydecanoic acid (UNII: NP03XO416B)  
    caryophyllene (UNII: BHW853AU9H)  
    sodium stearate (UNII: QU7E2XA9TG)  
    sodium salicylate (UNII: WIQ1H85SYP)  
    edetate disodium (UNII: 7FLD91C86K)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    chloroxylenol (UNII: 0F32U78V2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-992-011 in 1 CARTON
    1125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/12/2006
    Labeler - CLINIQUE LABORATORIES INC (173047747)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC Kabushiki Kaisha712808195RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    ARAMIS, INC042918826MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!