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Sulfur (Topical)


VA CLASSIFICATION
Sulfur Cream
Primary: DE500
Secondary: DE752

Sulfur Lotion
Primary: DE500
Secondary: DE752

Sulfur Ointment
Primary: DE500
Secondary: DE752; DE900; AP900

Sulfur Bar Soap
Primary: DE500
Secondary: DE752


Commonly used brand name(s): Cuticura Ointment; Finac; Fostex CM; Fostex Regular Strength Medicated Cover-Up; Fostril Cream; Fostril Lotion; Lotio Alsulfa; Sulpho-Lac.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Keratolytic (topical)—Sulfur Cream; Sulfur Lotion; Sulfur Ointment USP; Sulfur Bar Soap;

Antiacne agent (topical)—Sulfur Cream; Sulfur Lotion; Sulfur Ointment USP; Sulfur Bar Soap;

Antiseborrheic—Sulfur Ointment USP;

Scabicide—Sulfur Ointment USP;

Antirosacea agent (topical)—Sulfur Cream; Sulfur Lotion; Sulfur Ointment USP; Sulfur Bar Soap{34};

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Acne vulgaris {20} {26} {27} {29}(treatment)—Sulfur (cream, lotion, ointment {11}, and bar soap) is indicated as an aid in the treatment of acne vulgaris. {20}

Dermatitis, seborrheic (treatment)—Sulfur ointment is indicated for the treatment of seborrheic dermatitis. {20}

Scabies (treatment)—Sulfur ointment is indicated for the treatment of scabies, especially in infants under 2 months of age and in pregnant and nursing women. {18} {19} {20} {21} {22} {34}

[Rosacea (treatment)]—Sulfur (cream, lotion, ointment, and bar soap) {34} is used in strengths of up to 15% to treat rosacea. {26} {30} {34}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    32.06 {07}


Solubility
    Sulfur, precipitated: Practically insoluble in water; very soluble in carbon disulfide; slightly soluble in olive oil; very slightly soluble in alcohol.

Mechanism of action/Effect:

Sulfur has germicidal, fungicidal, parasiticidal, and keratolytic {20} actions. Its germicidal activity may be the result of its conversion to pentathionic acid by epidermal cells or by certain microorganisms.


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented. {19} {20} {22}

Breast-feeding

Problems in humans have not been documented. {19} {20} {22}

Pediatrics

Appropriate studies on the relationship of age to the effects of sulfur have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date. {19} {22}


Geriatrics


Appropriate studies on the relationship of age to the effects of sulfur have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Abrasive or medicated soaps or cleansers or
Acne preparations or preparations containing a peeling agent, such as
Benzoyl peroxide
Resorcinol
Salicylic acid
Tretinoin or
Acne preparations, topical, other or
Alcohol-containing preparations, topical, such as
After-shave lotions
Astringents
Perfumed toiletries
Shaving creams or lotions or
Cosmetics or soaps with a strong drying effect or
Isotretinoin or
Medicated cosmetics or ``cover-ups''    (concurrent use with sulfur may cause a cumulative irritant or drying effect, especially with the application of peeling, desquamating, or abrasive agents, resulting in excessive irritation of the skin)


Mercury compounds, topical    (concurrent use with sulfur may result in a chemical reaction releasing hydrogen sulfide, which has a foul odor, may be irritating, and may stain the skin black)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to sulfur


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
    
Skin irritation not present before therapy


Those indicating need for medical attention only if they continue or are bothersome
    
Redness and peeling of skin —may occur after a few days




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Sulfur (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to sulfur

Proper use of this medication
» Importance of not using more medication than the amount recommended

» Avoiding contact with the eyes

Proper administration

For cream and lotion dosage forms
Before applying—Washing affected areas with soap and water; drying thoroughly

Applying enough to cover affected areas; rubbing in gently

For ointment dosage form used for seborrheic dermatitis
Before applying—Washing affected areas with soap and water; drying thoroughly

Applying enough to cover affected areas; rubbing in gently

For ointment dosage form used for scabies
Before applying—Washing entire body with soap and water; drying thoroughly.

Applying enough at bedtime to cover entire body from neck down; rubbing in gently; leaving on body for 24 hours; washing entire body before applying again

Importance of washing entire body thoroughly 24 hours after the last treatment

For soap dosage form
Working up rich lather with soap, using warm {26} water

Washing affected areas and rinsing thoroughly

Applying lather again; rubbing in gently for a few minutes

Removing excess lather with a towel or tissue without rinsing

» Proper dosing
Missed dose: Using as soon as possible; not using if almost time for next dose

» Proper storage

Precautions while using this medication
» Avoiding simultaneous use with other topical acne preparations or preparations containing peeling agents, alcohol-containing preparations, abrasive soaps or cleansers, cosmetics or soaps with drying effect, medicated cosmetics, or other topical skin medication, unless otherwise directed by physician

» Avoiding concurrent use with topical mercury-containing preparations


Side/adverse effects
Signs of potential side effects, especially skin irritation not present before therapy


General Dosing Information
Before the ointment is applied, the affected areas should be washed with soap and water and then dried thoroughly.


Topical Dosage Forms

SULFUR CREAM

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, as needed. {02}


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


2% (OTC) [Fostex Regular Strength Medicated Cover-Up{02}]

Canada—


2% (OTC) [Fostex CM{15}] [Fostril Cream{14}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.


SULFUR LOTION

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, two or three times a day. {04}


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


2% (OTC) [Finac (alcohol 8%){11}] [Fostril Lotion{11}]


5% (OTC) [Lotio Alsulfa]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.
   • Shake well.


SULFUR OINTMENT USP

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, as a 0.5% ointment as needed. {11}

Antiseborrheic or
Keratolytic (topical)
Topical, to the skin, as a 5 to 10% ointment one or two times a day.

Scabicide
Topical, to the entire body from the neck down, as 6% sulfur in petrolatum at bedtime for 3 nights; patients may bathe before each application and should bathe 24 hours following the last application. {18} {19} {20} {21} {22} {34}

Note: Treatment may be repeated after 1 week if there is no clinical improvement; additional weekly treatments should be administered only if there are live mites. {22}



Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


0.5% (OTC) [Cuticura Ointment (phenol 0.1%) (oxyquinoline 0.05%){11}]


10% (OTC)[Generic]{03}

Note: Other strengths are not commercially available; compounding required for prescriptions.


Canada—
Not commercially available. Compounding required for prescriptions.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


SULFUR BAR SOAP

Usual adult and adolescent dose
Antiacne agent (topical) or
Keratolytic (topical)
Topical, to the skin, as needed.


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


5% (OTC) [Sulpho-Lac{10}]


10% (OTC)[Generic]{05}{11}

Canada—


10% (OTC)[Generic]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.



Revised: 10/28/1993



References

Note: All references used in the development and earlier revisions of this monograph have not yet been incorporated into the computer database and, therefore, are not listed below. Citations for information not yet referenced in the monograph will be provided upon request.

  1. Not used.
  1. Fostex Cream package insert (Westwood—US), Rec 6/87.
  1. Sulfur ointment generic package insert (Lilly—US), Rec 7/86.
  1. Lotio Alsulfa Lotion package insert (TCD—Canada), CPS 1990: 587.
  1. Sulfur soap generic package insert (Stiefel—Canada), CPS 1987: 827.
  1. Not used.
  1. Fleeger CA, editor. USAN 1993. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1992.
  1. Not used.
  1. Not used.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons, Inc. 1992: 545a.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons, Inc. 1992: 547, 549.
  1. Not used.
  1. Not used.
  1. Fostril Cream package insert (Westwood—Canada), CPS 1990: 425.
  1. Fostex CM cream package insert (Westwood—Canada), CPS 1990: 425.
  1. Not used.
  1. Not used.
  1. News from the American Academy of Dermatology 49th Annual meeting. Dermatology Nursing 1991 April; 3(2): 128.
  1. Maiback HI, Surber C, Orkin M. Sulfur revisited [letter]. J Am Acad Dermatol 1990 July; 23(1): 154-6.
  1. Lin AN, Reimer BA, Carter DM. Sulfur revisited. J Am Acad Dermatol 1988 Mar; 18(3) 553-8.
  1. Danish M. What is the recommended treatment of scabies in pregnant women? U.S. Pharmacist 1988 October: 24, 26.
  1. CDC. 1985 STD Treatment Guidelines. MMWR 1985 Oct 18; 34 (4S): 91S-92S.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Panel comments, 8/29/91.
  1. Strauss JS, Goldman PH, Nacht S, Gans EH. A reexamination of the potential comedogenicity of sulfur. Arch Dermatol 1978 Sep; 114(9): 1340-2.
  1. Not used.
  1. Mills OH Jr, Kligman AM. Is sulphur helpful or harmful in acne vulgaris? Br J Dermatol 1972 Jun; 86(6): 620-7.
  1. Blom I, Hornmark A. Topical treatment with sulfur 10 per cent for rosacea. Acta Derm Venereol (Stock) 1984; 64: 358-9.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Panel ballot comments, 10/24/91.
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