Label: NEUTROGENA STUBBORN ACNE SPOT DRYING- sulfur lotion

  • NDC Code(s): 69968-0761-1
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 13, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sulfur 10%

  • Purpose

    Acne treatment

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.

    Flammable: Keep away from fire or flame

    When using this product

    • Avoid contact with eyes. If contact occurs, immediately flush with water.
    • 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.
    • apply only to areas with acne.

    Do not use on

    ▪ broken skin ▪ large areas of the skin

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

  • Directions

    • Clean the 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.
    • Sensitivity Test for a New user: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

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  • Other Information

    • Store at room temperature
  • Inactive ingredients

    Isopropyl Alcohol, Water, Calamine, Niacinamide, Zinc Oxide, Zea Mays (Corn) Starch, Magnesium Aluminum Silicate, Salicylic Acid, Titanium Dioxide

  • Questions?

    800-582-4048; outside US, dial collect 215-273-8755 or visit www.neutrogena.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    JOHNSON & JOHNSON

    CONSUMER INC.


    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 29mL Bottle

    Neutrogena ®

    DERMATOLOGIST RECOMMENDED BRAND

    NEW

    STUBBORN

    ACNE

    SPOT DRYING LOTION

    Sulfur Acne Treatment

    10% Sulfur +

    4% Niacinamide

    Fragrance Free

    clears acne by drying up

    and shrinking pimples

    1 FL OZ (29mL)

    Neutrogena-001

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA STUBBORN ACNE SPOT DRYING 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0761
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0761-11 in 1 CARTON08/01/2022
    129 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/01/2022
    Labeler - Johnson & Johnson Consumer Inc. (118772437)