Label: AVARELLE ACNE TREATMENT SPOT SOLUTION- 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 June 29, 2018

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

  • Drug Facts

  • Active ingredient

    Salicylic Acid 1.5%

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment of acne
    • clears acne blemishes
    • helps prevent new acne blemishes
  • 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

    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Inactive ingredients

    Alcohol, Aloe Leaf Extract, Apple Fruit Extract, Bamboo Leaf/Stem Extract, Bergamot Fruit Oil, Betaine, Butylene Glycol, Caprylyl Glycol, Carbomer, Dipropylene Glycol, Disodium EDTA, Enantia Chlorantha Bark Extract, Ethylhexylglycerin, Glycerin, Glycolic Acid, Grape Fruit Extract, 1,2- Hexanediol, Kiwi Fruit Extract, Korean black raspberry Root Extract, Lactic Acid, Nordihydroguaiaretic acid, Oleanolic Acid, Peach Fruit Extract, PEG-60 Almond Glycerides, PEG-60 Hydrogenated Castor Oil, Pineapple Fruit Extract, Sodium Citrate, Strawberry Fruit Extract, Water, Willow Bark Extract, Xanthan Gum

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Questions?

    1-844-847-6682

  • SPL UNCLASSIFIED SECTION

    Salicylic Acid helps clear up acne blemishes and allows skin to heal

    Distributed by duogreen Inc.

    5801 West Side Ave Unit2,

    North Bergen, NJ 07047

    www.avarelle.com

    You may report serious side effects to the above US address

    MADE IN KOREA

    THIS PRODUCT IS NOT TESTED ON ANIMALS

  • Packaging

    Avarelle Acne Treatment Spot Solution

  • INGREDIENTS AND APPEARANCE
    AVARELLE ACNE TREATMENT SPOT SOLUTION 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72178-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    APPLE FRUIT OIL (UNII: 9NT987I3A8)  
    BAMBUSA VULGARIS WHOLE (UNII: WCD45M1BSK)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    RUBUS COREANUS FRUIT (UNII: 18VM55XVF7)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    PEACH (UNII: 3OKE88I3QG)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    STRAWBERRY JUICE (UNII: U8NS58UGW0)  
    WATER (UNII: 059QF0KO0R)  
    WILLOW BARK (UNII: S883J9JDYX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72178-201-011 in 1 CARTON06/29/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/29/2018
    Labeler - Duogreen (017204805)