Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 217c697e-0260-46d5-a202-ce7345eadd94
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (100 mg)
Inactive Ingredients
Water Niacinamide Glycolic Acid Stearyl Alcohol Glycerin Phenoxyethanol Sodium Hydroxide Peg-100 Stearate Phenylethyl Resorcinol Allantoin Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-01
Description

Sulfur 10%

Purpose

Acne treatment

Medication Information

Purpose

Acne treatment

Description

Sulfur 10%

Use

for the treatment of acne

Section 51945-4

Warnings

For external use only

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
Do Not Use On
  • broken skin
  • large areas of the skin
Active Ingredient



Sulfur 10%

Inactive Ingredient

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, magnesium aluminum silicate, phenoxyethanol, polyacrylamide, ceteareth-20, sodium hydroxide, PEG-100 stearate, phenylethyl resorcinol, tocopheryl acetate, C13-14 isoparaffin, disodium EDTA, laureth-7, allantoin, aloe barbadensis leaf juice, hydrogenated lecithin, ethylhexylglycerin, glycyrrhiza glabra (licorice) root extract

Questions Or Comments?

Call toll free 1-800-946-4453

When Using This Product
  • 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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

for the treatment of acne

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

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
Do Not Use On (Do not use on)
  • broken skin
  • large areas of the skin
Active Ingredient (Active ingredient)



Sulfur 10%

Inactive Ingredient (Inactive ingredient)

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, magnesium aluminum silicate, phenoxyethanol, polyacrylamide, ceteareth-20, sodium hydroxide, PEG-100 stearate, phenylethyl resorcinol, tocopheryl acetate, C13-14 isoparaffin, disodium EDTA, laureth-7, allantoin, aloe barbadensis leaf juice, hydrogenated lecithin, ethylhexylglycerin, glycyrrhiza glabra (licorice) root extract

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

When Using This Product (When using this product)
  • 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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:37.266756 · Updated: 2026-03-14T23:02:16.200124