Label: UTILIDERM ACNE CONTROL- sulfur,resorcinol gel

  • 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 March 24, 2018

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Sulfur 4%

    Resorcinol 2%

  • PURPOSE

    Purpose

    acne medication

    acne medication

  • INDICATIONS & USAGE

    Use

    for the treatment of acne

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use on

    ■ broken skin ■ large areas of the skin

  • WHEN USING

    When using this product

    ■ apply only to areas with acne ■ rinse eyes right

    away with water if it gets in eyes ■ 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.

  • STOP USE

    Stop use and ask a doctor if skin irritation occurs

    or gets worse.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get

    medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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.

  • INFORMATION FOR PATIENTS

    Other information

    ■ keep tightly closed ■ keep away from heat

    ■ Report serious adverse reaction to:

    c/o Report Reaction, LLC, P.O. Box 22,

    Plainsboro, New Jersey 08536-0222

  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzalkonium chloride, bergamot essential oil,

    carbomer U-10, chitosan, Melaleuca alternifolia leaf

    essential oil, Nigella sativa seed oil, olive oil, Origanum

    vulgare whole plant essential oil, polysorbate 80,

    sorbitan.

  • QUESTIONS

    Questions or comments?

    Call toll free 1-800-781-7723.

    Weekdays from 9 AM - 4 PM, Eastern time.

  • PRINCIPAL DISPLAY PANEL

    Capture.jpg

  • INGREDIENTS AND APPEARANCE
    UTILIDERM ACNE CONTROL 
    sulfur,resorcinol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71493-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR4 mg  in 100 mL
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN (UNII: 6O92ICV9RU)  
    CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ORIGANUM VULGARE SUBSP. HIRTUM WHOLE (UNII: 38SNL0F81Z)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Product Characteristics
    Coloryellow (light) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71493-001-251 in 1 CARTON04/02/2018
    125 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/02/2018
    Labeler - Sante Naturelle (A.G.) Ltee (207933979)
    Registrant - Delta Pharma Inc (200161730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Pharma Inc.200161730manufacture(71493-001)