Label: AVEDA OUTER PEACE ACNE RELIEF PADS- salicylic acid solution

  • 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 May 19, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic acid 1.5%

  • Purpose

    Acne treatment

  • Use

    • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • cleanse skin thoroughly before applying
    • cover the entire affected area with one application daily
    • gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to every other day
    • if going outside, use a sunscreen. Allow product to dry, then follow sunscreen directions. If sensitivity develops, discontinue use of both products and consult a doctor.
  • Inactive ingredients

    Water/Aqua/Eau, Alcohol Denat., Betaine, PEG-60 Almond Glycerides, Calophyllum Inophyllum (Tamanu) Seed Oil, Boswellia Serrata Extract, Phyllanthus Emblica Fruit Extract, Serenoa Serrulata (Saw Palmetto) Fruit Extract, Caffeine, Sodium Salicylate, Fragrance (Parfum)1 <ILN30711>


    1
    Aveda's Own Pure-FumeAroma with Certified Organic Lemon Tea Tree and Rose Geranium Oils and Other Pure Flower and Plant Essences
  • PRINCIPAL DISPLAY PANEL - 50 Pad Jar Carton

    AVEDA
    THE ART AND SCIENCE OF PURE
    FLOWER AND PLANT ESSENCES

    outer peace

    acne relief pads

    salicylic acid treatment delivers medicine deep into pores

    50 pads

    PRINCIPAL DISPLAY PANEL - 50 Pad Jar Carton
  • INGREDIENTS AND APPEARANCE
    AVEDA OUTER PEACE ACNE RELIEF PADS 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57677-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BETAINE (UNII: 3SCV180C9W)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57677-064-011 in 1 CARTON05/17/2021
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D05/17/2021
    Labeler - Aveda Corporation (071352058)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277MANUFACTURE(57677-064) , REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(57677-064) , REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326MANUFACTURE(57677-064) , REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(57677-064) , REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd204132062REPACK(57677-064) , RELABEL(57677-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC PALC102631997REPACK(57677-064) , RELABEL(57677-064)