Label: NEUTROGENA NATURALS ACNE SPOT TREATMENT- salicylic acid lotion

  • NDC Code(s): 10812-024-01
  • Packager: Neutrogena Corporation
  • 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 06/15

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Salicylic Acid 1%

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  • Purpose

    Acne medication

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  • Use

    For the treatment of acne.

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  • 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.
    • if eye contact occurs, flush thoroughly with water.

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

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  • Directions

    • Cleanse skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to three times daily
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
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  • Other information

    Store at Room Temperature.

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  • Inactive ingredients

    water, hydrated silica, glycerin, dicaprylyl carbonate, cetearyl alcohol, magnesium aluminum silicate, hydroxypropyl starch phosphate, coco-glucoside, benzyl alcohol, sodium benzoate, xanthan gum, cetearyl glucoside, sodium hydroxide, fragrance, sodium phytate, butylene glycol, cedrus atlantica bark extract, portulaca oleracea extract

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  • Questions?

    Call toll-free 800-582-4048 or 215-273-8755 (collect) or visit www.NeutrogenaNaturals.com

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  • SPL UNCLASSIFIED SECTION

    Dist. by Neutrogena Corp.
    Los Angeles, CA 90045

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  • PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

    NEW INFO

    Neutrogena®
    naturals

    NO
    harsh chemical
    sulfates, parabens,
    petrochemicals,
    dyes, phthalates

    Acne
    Spot Treatment

    Clinically proven acne medicine treats and helps
    prevent breakouts

    Fortified with Wintergreen leaf derived acne-fighting
    Bionutrient for clear, healthy-looking skin

    DERMATOLOGIST RECOMMENDED BRAND
    SALICYLIC ACID ACNE TREATMENT
    93% naturally derived

    0.75 FL.OZ. (22mL)

    Principal Display Panel - 22 mL Tube Carton
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  • INGREDIENTS AND APPEARANCE
    NEUTROGENA NATURALS ACNE SPOT TREATMENT 
    salicylic acid lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-024
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Coco Glucoside (UNII: ICS790225B)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Phytate Sodium (UNII: 88496G1ERL)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cedrus Atlantica Bark (UNII: ITP1Q41UPF)  
    Purslane (UNII: M6S840WXG5)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10812-024-01 1 in 1 CARTON
    1 22 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 11/01/2012
    Labeler - Neutrogena Corporation (008254617)
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