UTILIDERM ACNE CONTROL (SULFUR,RESORCINOL) GEL [SANTE NATURELLE (A.G.) LTEE]

UTILIDERM ACNE CONTROL (SULFUR,RESORCINOL) GEL [SANTE NATURELLE (A.G.) LTEE]
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NDC 71493-001-25
Set ID 682e804d-d5bc-c6b4-e053-2a91aa0a25f2
Category HUMAN OTC DRUG LABEL
Packager Sante Naturelle (A.G.) Ltee
Generic Name
Product Class
Product Number
Application Number PART333D
  • 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)

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