Label: SANTALIA CLINICAL INTENSTIVE SPOT TREATMENT - salicylic acid gel

  • NDC Code(s): 76358-192-01, 76358-192-02, 76358-192-03
  • Packager: Santalis Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/14

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2%

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  • PURPOSE

    Purpose.......Acne Treatment

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  • WARNINGS

    Warnings

    For External use only

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  • When using this product

    Using other topical acne products at the same time or immediately following the use of this product may increase dryness or irritation of the skin.  If this occurs, only one product should be used unless directed by a physician.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • DO NOT USE

    Do not use around eye area.  If contact occurs, flush thoroughly with water.  If irritation develops, discontinue use.

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  • DOSAGE & ADMINISTRATION

    Directions  Clean skin.  Cover affected area with a thin layer 1-3 times daily.  Because excessive drying of the skin may occur, start with one application daily, then increase to 2 or 3 times daily or directed by a doctor.  If dryness or peeling occurs, reduce to once a day or every other day.

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  • INACTIVE INGREDIENT

    Inactive ingredients

    SD ALCOHOL 40-B, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, FUSANUS SPICATUS WOOD OIL, SANTALUM ALBUM WOOD OIL, HYDROXYPROPYLCELLULOSE, BUTYLENE GLYCOL, ALLIUM CEPA BULK EXTRACT, BACKHOUSIA CITRIODORA LEAF EXTRACT, OCTYLDODECANOL, CARDIOSPEMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, ECHIUM PLATAFINEUM SEED OIL, WATER, HELIANTHUS ANNUUS (SUNFLOWER) SEE OIL UNSAPONIFIABLES.

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  • QUESTIONS

    Questions or Comments? 1-877-397-0546

    For Australia orders, contact Mt Romance Au Pty Ltd

    1300 362 132

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  • HOW SUPPLIED

    Manufactured in USA. Distributed by Santalis Pharmeceuticals, Inc.

    San Antonio, TX Santalia is a registered trademark of Santalis Pharmaceuticals, Inc.  US and Foreign patents pending.

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  • INDICATIONS & USAGE

    Neutralizes stubborn blimishes while controlling new breakouts before they emerge.
    Sandalwood Essence, Witch Hazel and Lemon Myrtle help calm skin while blemishes heal.
    Free of Parabens, Sulfates, Benzoyl Peroxide and artificial dyes and fragrance.

    Dermatologist tested.
    Not tested on animals.

    www.SANTALIASHOP.com

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  • PRINCIPAL DISPLAY PANEL


    Spottreatmentcartn

    Santalia

    Clinical
    Acne

    intensive Spot Treatment



    Reduces Blemishes with a purifying Australian Sandalwood Blend.



    naturally source, clinically proven

    15mL (.5 fl oz)

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  • INGREDIENTS AND APPEARANCE
    SANTALIA CLINICAL INTENSTIVE SPOT TREATMENT  
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76358-192
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2.18 g  in 100.00 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    SANTALUM SPICATUM OIL  
    1,3-BUTYLENE GLYCOL  
    WATER  
    BACKHOUSIA CITRIODORA LEAF  
    PHENOXYETHANOL  
    ONION  
    OCTYLDODECANOL  
    ECHIUM PLANTAGINEUM SEED OIL  
    SUNFLOWER OIL  
    CARDIOSPERMUM HALICACABUM FLOWERING TOP  
    TOCOPHEROL  
    HAMAMELIS VIRGINIANA TOP WATER  
    BENZOIC ACID  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76358-192-02 1 in 1 CARTON
    1 NDC:76358-192-01 15.00 mL in 1 TUBE
    2 NDC:76358-192-03 2.00 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2013
    Labeler - Santalis Pharmaceuticals (963047027)
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