Label: BLEMISH VANISHING- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

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 5, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
  • 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.
  • Directions

    • Clean the skin thoroughly before applying this product.
    • Cover the affected area with a thin layer 1-3 times daily.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2-3 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.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Vegetable Glycerin, Ethyl Alcohol1, Hamamelis Virginiana (Witch Hazel) Distillate1, Fruit Stem Cells (Argan, Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Hydroxyethyl Cellulose, Salix Alba (Willow Bark) Extract1, Spiraea Ulmaria (Meadowsweet) Extract1, Epilobium Angustifolium (Willow Herb) Extract, Magnesium Ascorbyl Phosphate (Vitamin C), Zinc Gluconate, Camellia Sinensis (White Tea) Leaf Extract12, Tocopherol, Arnica Montana Flower Extract, Lavandula Officinalis (Lavender) Flower Extract1, Chamomilla Recutita (Chamomile) Flower Extract1, Calendula Officinalis Flower Extract1, Cinnamomum Camphora (Camphor) Bark Oil, Mentha Piperita (Peppermint) Leaf Oil1, Thymus Vulgaris (Thyme) Oil1

    1
    Certified Organic
    2
    Fair Trade Ingredients
  • Questions

    Call (888) 898-6955 or visit www.Andalou.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Andalou Naturals
    Novato, CA 94945 USA

  • PRINCIPAL DISPLAY PANEL - 18 mL Tube Carton

    IMPROVED!

    ANDALOU
    NATURALS

    NON
    GMO

    Blemish
    VANISHING
    GEL

    Maximum Strength

    with Argan Stem Cells
    Energized Renewal

    FRUIT
    STEM
    CELL
    SCIENCE®

    CLEARSKIN

    NPN 80064743

    .6 fl oz e 18 mL

    Principal Display Panel - 18 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    BLEMISH VANISHING 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-1810
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    APPLE (UNII: B423VGH5S9)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ACAI (UNII: 46AM2VJ0AW)  
    ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    WILLOW BARK (UNII: S883J9JDYX)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    WHITE TEA (UNII: O0M3396E09)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    THYME OIL (UNII: 2UK410MY6B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-1810-11 in 1 CARTON03/01/2011
    118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D03/01/2011
    Labeler - Andalou naturals (011472720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc189788201MANUFACTURE(55560-1810)
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