UNAGEL (SALICYLIC ACID) CREAM [ADVANCED SKIN TECHNOLOGY, LLC]

UNAGEL (SALICYLIC ACID) CREAM [ADVANCED SKIN TECHNOLOGY, LLC]
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NDC 52205-001-00
Set ID a6f6f2df-87e3-415d-97a7-308663899deb
Category HUMAN OTC DRUG LABEL
Packager Advanced Skin Technology, LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2 percent

  • Purpose

    Acne Medication

  • Uses

    for the treatment of acne

  • Warnings

    For External Use Only

    When using this product with other topical medications, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • Directions

    • cleanse thoroughly before applying medication.
    • cover affected area with thin layer one to three times daily.
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • recommended for daily use.
  • Inactive ingredients

    aqua, disodium phosphate, propylene glycol, butylene glycol, PEG-12 dimethicone, carbomer, triethanolamine, phragmites, kharka extract, poria cocos extract, camellia oleifera (green tea) leaf extract, xanthan gum, disodium EDTA, alkyl acrylate, methacrylate copolymer, propyl alcohol, phenoxyethanol, vitis vinifera (grape) seed oil, methylparaben, butylparaben, ethylparaben, propyl paraben, menthol

  • Questions

    1-866-642-7546

    www.AdvancedSkinTech.com

  • PRINCIPAL DISPLAY PANEL

    BENEFITS

    Prevents acne by promoting gentle exfoliation which can unclog pores.
    Penetrates the pore to treat acne blemishes.
    Helps reduce the appearance of irritated redness.
    Reduces the number and severity of acne blemishes.
    Helps prevent the formation of new acne and allows the skin to heal itself.
    Light, non-greasy gel formulation feels cool and gentle to the skin.
    Non-pore clogging, fragrance free formula.
    Ideal formula for sensitive skin.

    Best results can be achieved when used in conjunction with a topical retinoid like Green Cream - high potency retinol



    CARE AND CAUTION

    Test a small patch of skin and wait 24 hours before you continue use of this product.
    Wear a broad-spectrum sunscreen while using this product.
    Avoid contact with the eyes. If product gets in the eye, rinse thoroughly with water.
    Suspend use if skin becomes irritates. Seek medical help if reaction is severe.
    For external use only; do not ingest.
    Keep out of reach of children.
    Do not use if allergic to aspirin.

    Disclaimer: This product is an active product that should be used with caution and care. Please read all instructions and contact us if you have any questions or concerns. Advanced Skin Technology, LLC does not make any warranties; whether expressed or implied with respect to the use of this product as it relates to fitness for a particular purpose, or for any other matter. The buyer's sole remedy for any claim against the manufacturer or distributor shall be limited to the replacement of the product.

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  • INGREDIENTS AND APPEARANCE
    UNAGEL 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52205-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYL ALCOHOL (UNII: 96F264O9SV)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FU LING (UNII: XH37TWY5O4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHRAGMITES KARKA WHOLE (UNII: 10086A360Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52205-001-0029 g in 1 BOTTLE; Type 0: Not a Combination Product09/04/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/04/2012
    Labeler - Advanced Skin Technology, LLC (130977940)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Skin Technology, LLC130977940manufacture(52205-001)

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