Label: ACNE CLEANSER W/ SALICYLIC ACID- 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 December 1, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient: Salicylic Acid 2%

  • PURPOSE

    Acne Treatment

  • INDICATIONS & USAGE

    Uses: Treats acne

    dries up acne

    help prevent new acne

  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use :

    on the broken skin

    if pregnant or lactating

  • WHEN USING

    avoid unnecessary sun exposure and use a sunscreen.

    do not use in or near the eyes.

    not that using other topical acne drugs at the same time or right after use of this product may increase dryness or skin irritation.

  • STOP USE

    Stop useand ask a doctor if too much skin irritation or sensitivity develops or increase.

  • KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    gently massage cleanser onto skin and remove with lukewarm water.

    use once daily, alternating use with another, non drug cleanser.

    if bothersome dryness or peeling occurs, reduce application to every other day.

  • OTHER SAFETY INFORMATION

    store at 19-24 C (66-75 F)

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Sorbitol, Ammonium Lauryl Sulfate, Cetyl Alcohol, Stearyl Alcohol, PPG-12/SMDI Copolymer, Phenoxyethanol, CAprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

  • PRINCIPAL DISPLAY PANEL

    Physician's Aesthetic Research, Inc Distr.

    San Clemente, CA 92672

    www.lucrece.com

    Made in USA

    Acne Cleanser 60

  • INGREDIENTS AND APPEARANCE
    ACNE CLEANSER W/ SALICYLIC ACID 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4107-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2017
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4107)
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