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Salicylic Acid and Sulfur (Topical)


VA CLASSIFICATION
Bar
Primary: DE500
Secondary: DE752

Cleansing Lotion
Primary: DE500
Secondary: DE752

Shampoo
Primary: DE500
Secondary: DE900


Commonly used brand name(s): Essential Care Creamy Dandruff Shampoo; Essential Care Maximum Strength Dandruff Shampoo; Essential Care Medicated Dandruff Wash; Meted; Pernox (Lemon); Pernox (Regular); Pernox Lathering Abradant Scrub Cleanser (Fresh Scent); SAStid Soap; Sebex; Sebulex; Sebulex (Regular); Sebulex (with Conditioners).

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



Category:


Keratolytic (topical)—Salicylic Acid and Sulfur;

Antiacne agent (topical)—Salicylic Acid and Sulfur Bar; Salicylic Acid and Sulfur Cleansing Lotion;

Antiseborrheic (topical)—Salicylic Acid and Sulfur Bar; Salicylic Acid and Sulfur Shampoo;

Indications

Accepted

Acne vulgaris (treatment) or
Oily skin (treatment)—Salicylic acid and sulfur combination (bar or cleansing lotion) is indicated for the treatment of acne and oily skin {05} {09}.

Dandruff (treatment) or
Dermatitis, seborrheic, of scalp (treatment)—Salicylic acid and sulfur (bar or shampoo) is indicated for the temporary control of scaling and itching associated with dandruff and seborrheic dermatitis of the scalp {01} {08} {10} {13}.


Pharmacology/Pharmacokinetics

Salicylic Acid—See Salicylic Acid (Topical) .

Sulfur—See Sulfur (Topical) .


Precautions to Consider

Salicylic Acid—See Salicylic Acid (Topical) .

Sulfur—See Sulfur (Topical) .


Side/Adverse Effects
Salicylic Acid—See Salicylic Acid (Topical) .
Sulfur—See Sulfur (Topical) .



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Salicylic Acid and Sulfur (Topical).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

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





Use in children—Young children may be at increased risk of toxicity because of increased absorption of salicylic acid through the skin


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

Washing hands immediately after application to remove any medication that may be on them

» Avoiding contact with the eyes

Proper administration

For skin cleansing lotion dosage form
After wetting skin—Applying medication with fingertips or a wet sponge; rubbing in gently to work up lather; rinsing thoroughly and patting dry

For lotion dosage form
Applying small amount to affected area; rubbing in gently

For shampoo dosage form
Wetting hair and scalp with lukewarm water

Applying enough to work up lather; rubbing into scalp

Continuing to rub lather into scalp for several minutes or allowing to remain on scalp for about 5 minutes, depending on product

Applying medication again; rinsing thoroughly

For bar dosage form
Using as a soap, wetting skin and washing face and other affected areas; rinsing thoroughly; patting dry

Using as a shampoo, wetting hair and scalp with lukewarm water, lathering and rubbing into scalp, leaving on scalp for about 5 minutes, rinsing and reapplying medication; rinsing thoroughly

» 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

Caution if medications containing aspirin or other salicylates are used


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


General Dosing Information
Since salicylic acid can be absorbed through the skin, this medication should not be applied over large areas of the body or for prolonged periods of time, particularly in the very young.


Topical Dosage Forms

SALICYLIC ACID AND SULFUR BAR

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the affected skin, two or three times a day {08}.

Dandruff
Topical, to the affected skin of the scalp, once a day at least two times a week to maintain control or as directed by physician. Apply after wetting hair, lather, massage into affected scalp, leave on scalp for five minutes, rinse, and repeat. May be used once a day if needed {07}.


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


3% salicylic acid and 5% precipitated sulfur (OTC)[Generic]{07}

Canada—


3% salicylic acid and 10% precipitated sulfur (OTC) [SAStid Soap{08}]

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.


SALICYLIC ACID AND SULFUR CLEANSING LOTION

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, one to three times a day. Massage lather into wet skin for one minute then rinse {05} {09}.


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


1.5% salicylic acid and 2% sulfur (OTC) [Pernox (Lemon){09}] [Pernox (Regular){09}] [Pernox Lathering Abradant Scrub Cleanser (Fresh Scent){11}]

Canada—


1.5% salicylic acid and 2% sulfur (OTC) [Pernox (Lemon){05}] [Pernox (Regular){05}]

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:
   • Shake well.
   • For external use only.


SALICYLIC ACID AND SULFUR SHAMPOO

Usual adult and adolescent dose
Dandruff or
Dermatitis, seborrheic, of scalp
Topical, to the affected skin of the scalp, once a day at least two times a week to maintain control or as directed by physician. Apply after wetting hair, lather, massage into affected scalp, leave on scalp for five minutes, rinse, and repeat. May be used once a day if needed {01}.


Usual pediatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


2% salicylic acid and 2% colloidal sulfur (OTC) [Sebex{03}]


2% salicylic acid and 2% sulfur (OTC) [Essential Care Creamy Dandruff Shampoo{13}] [Sebulex (Regular){01}] [Sebulex (with Conditioners){01}]


2% salicylic acid and 4% sulfur (OTC) [Essential Care Medicated Dandruff Wash{14}]


3% salicylic acid and 5% sulfur (OTC) [Essential Care Maximum Strength Dandruff Shampoo{10}] [Meted{12}]

Canada—


2% salicylic acid and 2% sulfur (OTC) [Sebulex{04}]


3% salicylic acid and 5% sulfur (OTC) [Meted{02}]

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:
   • Shake well.
   • For external use only.



Revised: 08/13/1998



References
  1. Sebulex packaging (Westwood Squibb—US), Rev 1990, Rec 3/10/98.
  1. Meted packaging (GenDerm—Canada), Rev 1/92, Rec 2/13/98.
  1. Sebex packaging (Rugby—US), Rev 11/94, Rec 7/15/98.
  1. Sebulex packaging (Westwood-Squibb—Canada), Rec 6/2/98.
  1. Pernox packaging (Westwood-Squibb—Canada), Rec 6/02/98.
  1. Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 653, 696.
  1. Salicylic Acid and Sulfur Soap Antidandruff Cleanser packaging (Stiefel—US), Rev 3/94, Rec 7/20/98.
  1. SAStid (Stiefel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1510.
  1. Pernox packaging (Westwood-Squibb—US), Rev 1990, Rec 3/10/98.
  1. Essential Care Maximum Strength Dandruff Shampoo packaging (C&M Pharmacal—US), Rec 7/27/98.
  1. Pernox packaging (Westwood-Squibb—US), Rec 8/03/98.
  1. Meted package insert (GenDerm—US), Rev 1990, Rec 12/90.
  1. Essential Care Creamy Dandruff Shampoo packaging (C&M Pharmacal—US), Rev 3/98, Rec 7/27/98.
  1. Essential Care Medicated Dandruff Wash packaging (C&M Pharmacal—US), Rec 7/27/98.
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