Label: SANTALIA CLINICAL ACNE- salicylic acid   

  • Label RSS
  • NDC Code(s): 76358-192-01, 76358-194-01, 76358-195-02, 76358-196-01
  • 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

    Daily Cleanser                                   

    Active Ingredient: Salicylic Acid  0.5%

    Daily Serum

    Active Ingredient:   Salicylic Acid  0.5%

    Spot Treatment

    Active Ingredient:   Salicylic Acid 2%

    Purpose:  Acne Treatment

    Use

    For the Treatment of Acne

    Warnings For external Use Only

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


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

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

    Directions

    Daily Cleanser:

    Apply foam to wet face with washcloth or very soft brush am and pm.  Rinse thoroughly with cool water and pat dry.  Use on neck and chest as needed.

    Daily Serum

    Apply to cleansed skin am and pm.  For maintenance, use once a day. Treat individual blemishes with SANTALIA SPOT TREATMENT as needed.

    Intensive Spot Treatment

    Apply to Blemishes as needed, up to 3 times a day.

    Daily Cleanser

    Inactive ingredients  WATER, LAURAMIDOPROPYL BETAIN, SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE, POLYSORBATE 80, GLYCERIN, TERMINALIA FERDINANDIANA FRUIT EXTRACT, ALCOHOL, BUTYLENE GLYCOL, BACKHOUSIA CITRIODORA LEAF EXTRACT, LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) EXTRACT, CITRIC ACID SANTALUM ALBUM WOOD OIL, FUSANUS SPICATUS WOOD OIL, TANGERINE OIL, GRAPEFRUIT OIL.

    Daily Serum

    Inactive Ingredients:  WATER, ISODECYL NEOPENTANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, FUSANUS SPICATUS WOOD OIL, SANTALUM ALBUM WOOD OIL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7 HYDROLYZED ALGIN, ZINC SULFATE, GLYCERIN, TERMINALIA FERDINANDIANA FRUIT EXTRACT, ALCOHOL, BUTYLENE GLYCOL, BACKHOUSIA CITRIODORA LEAF EXTRACT, LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) EXTRACT, CITRIC ACID, BUTYL AVOCADATE, FUSANUS SPICATUS NUT OIL.

    Intensive Spot Treatment

    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.

    Questions or Comments?  1-800-397-0546

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  • INGREDIENTS AND APPEARANCE
    SANTALIA CLINICAL ACNE 
    salicylic acid kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76358-196
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76358-196-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, PUMP 120.0 mL
    Part 2 1 TUBE 15.0 mL
    Part 3 1 TUBE 30.0 mL
    Part 1 of 3
    SANTALIA CLINICAL DAILY CLEANSER 
    salicylic acid soap
    Product Information
    Item Code (Source) NDC:76358-195
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.54 g  in 100.00 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    TERMINALIA BELLIRICA FRUIT  
    1,3-BUTYLENE GLYCOL  
    ALCOHOL  
    BACKHOUSIA CITRIODORA LEAF  
    PHENOXYETHANOL  
    SODIUM LAURYL SULFATE  
    LONICERA CAPRIFOLIUM FLOWER  
    LONICERA JAPONICA FLOWER  
    CITRIC ACID MONOHYDRATE  
    LAURAMIDOPROPYL BETAINE  
    SODIUM CHLORIDE  
    DMDM HYDANTOIN  
    POLYSORBATE 80  
    SANTALUM SPICATUM OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76358-195-02 120.0 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2013
    Part 2 of 3
    SANTALIA CLINICAL INTENSTIVE SPOT TREATMENT 
    salicylic acid gel
    Product Information
    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:76358-192-01 15.0 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2013
    Part 3 of 3
    SANTALIA CLINICAL DAILY SERUM 
    salicylic acid gel
    Product Information
    Item Code (Source) NDC:76358-194
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.54 g  in 100.00 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    1,3-BUTYLENE GLYCOL  
    ALCOHOL  
    SODIUM ALGINATE  
    ZINC SULFATE  
    BACKHOUSIA CITRIODORA LEAF  
    PHENOXYETHANOL  
    POLYACRYLAMIDE (1500 MW)  
    C13-14 ISOPARAFFIN  
    LAURETH-7  
    LONICERA CAPRIFOLIUM FLOWER  
    LONICERA JAPONICA FLOWER  
    CITRIC ACID MONOHYDRATE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    ISODECYL NEOPENTANOATE  
    AVOCADO  
    SANTALUM SPICATUM OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76358-194-01 30.0 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 02/01/2013
    Labeler - Santalis Pharmaceuticals (963047027)
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