Label: DR YOUNG AC CONTROL AC OUT SPOT STOP SERUM- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 5, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Salicylic Acid 0.1%

  • INACTIVE INGREDIENT

    Inactive ingredients: Alcohol, Water, Butylene Glycol, Chrysanthemum Morifolium Flower Extract, Magnolia Kobus Bark Extract, Camellia Sinensis Leaf Extract, Thujopsis Dolabrata Branch Extract, Citrus Grandis(Grapefruit) Fruit Extract, Cnidium Officinale Root Extract, Acorus Calamus Root Extract, Artemisia Princeps Leaf Extract, Sophora Angustifolia Root Extract, Prunus Mume Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamaecyparis Obtusa Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Fragrance

  • PURPOSE

    Purpose: Acne Treatment

  • WARNINGS

    Warning: 1) For external use only. 2) Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. 3) If this occurs, only one drug should be used unless directed by a doctor. 4) Avoid direct contact with eyes. 5) If contact occurs, flush thoroughly with water. 6) If swallowed, get medical help or contact a Poison Control Center right away. 7) Not to be used for children under 3 years of age.

    Storage and cautions for handling: 1) Keep out of reach of children. 2) Keep away from high or low temperature and direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: Acne treatment spot serum containing green tea and white tea extracts soothes irritated area effectively. Ultralight transparent gel delivers reduced inflammation on contact.

  • Directions

    Directions: Apply small amount by tapping lightly onto acne spot areas. Apply over makeup if necessary.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR YOUNG AC CONTROL AC OUT SPOT STOP SERUM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-1340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.01 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43948-1340-21 in 1 CARTON10/01/2017
    1NDC:43948-1340-115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2017
    Labeler - Tdc, Co. Ltd (687479378)
    Registrant - Tdc, Co. Ltd (687479378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biocostec Co., Ltd.690407325manufacture(43948-1340)