Label: ACNE ADVANCED CLEANSING- salicylic acid liquid

  • NDC Code(s): 15751-3010-5
  • Packager: Eminence Organic Skin Care Ltd.
  • 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 November 14, 2018

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

View All Sections
  • Drug Facts

  • Active ingredient

    Salicylic Acid 1%

    Purpose

    Acne Treatment

  • Use

    • For the treatment of acne.
  • Warnings

    For external use only

    When using this product

    • Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, use only one product at a time.
    • Avoid eye area. In case of eye contact, flush gently and thoroughly with water.

    Keep out of reach of children.

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

  • Direcitons

    • Use 1 to 3 times daily.
    • Pump a small amount of product to transform the liquid into a lightweight foam. Apply to skin and massage gently with fingertips in a circular motion covering the face and neck. Rinse thoroughly and pat dry.
    • Because excessive drying of the skin may occur, strar with one application daily, then gradually increase to 2 ot 3 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.
  • Other information

    Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

  • Inactive ingredients

    Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) Peel Extract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glyceri], Decyl Glucoside, Sodium Cocoyl Glutamate, Citrus Grandis (Grapefruit) Peel Oil, Metha Spicata (Spearmint) Leaf Oil, Caprylyl Glycol, Tocopherol (Vitamin E), Panthenol (Provitamin B5), Thymus Vulgans (Thyme) Extract, Cinnamomum Zeylanicum (Cinnamon) Bark Extract, Ole Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Cocamidopropyl Dimethylamine, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Ethylhexylglycerin, Caffeine (from Green Tea), Sodium PCA, Arbutin, Biocomplex2 [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10), Vegetable Glycerin.
    *Certified organic ingredient

  • Package Labeling for Box:

    Label

  • Package Labeling for Bottle:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ACNE ADVANCED CLEANSING 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-3010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BETA VULGARIS (UNII: 4G174V5051)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    THYME (UNII: CW657OBU4N)  
    CINNAMON (UNII: 5S29HWU6QB)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSEMARY (UNII: IJ67X351P9)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    LEMON (UNII: 24RS0A988O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ARBUTIN (UNII: C5INA23HXF)  
    ACAI (UNII: 46AM2VJ0AW)  
    CARROT (UNII: L56Z1JK48B)  
    COCONUT (UNII: 3RT3536DHY)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-3010-51 in 1 BOX09/01/2018
    1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/01/2018
    Labeler - Eminence Organic Skin Care Ltd. (205753317)
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!