Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d7cc3c06-2f89-4c0b-b121-fdd53638b625
Route
TOPICAL
Published
Effective Date 2024-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (100 mg)
Inactive Ingredients
Water Niacinamide Starch, Corn Glycolic Acid Stearyl Alcohol Glycerin Octyldodecyl Myristate Cetostearyl Alcohol Glyceryl 1-stearate Sodium Hydroxide Magnesium Aluminum Silicate Phenoxyethanol Polyacrylamide (10000 Mw) Polyoxyl 20 Cetostearyl Ether Peg-100 Stearate .alpha.-tocopherol Acetate Phenylethyl Resorcinol C13-14 Isoparaffin Edetate Disodium Laureth-7 Allantoin Hydrogenated Soybean Lecithin Ethylhexylglycerin Maltodextrin Glycyrrhiza Glabra Aloe Vera Leaf Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15

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 Ingredients

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, sodium hydroxide, magnesium aluminum silicate, phenoxyethanol, polyacrylamide, ceteareth-20, PEG-100 stearate, tocopheryl acetate, phenylethyl resorcinol, c13-14 isoalkane, disodium EDTA, laureth-7, allantoin, hydrogenated lecithin, ethylhexylglycerin, maltodextrin, glycyrrhiza glabra (licorice) root extract, aloe barbadensis leaf juice powder, silica

Questions Or Comments?

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 Ingredients (Inactive ingredients)

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, sodium hydroxide, magnesium aluminum silicate, phenoxyethanol, polyacrylamide, ceteareth-20, PEG-100 stearate, tocopheryl acetate, phenylethyl resorcinol, c13-14 isoalkane, disodium EDTA, laureth-7, allantoin, hydrogenated lecithin, ethylhexylglycerin, maltodextrin, glycyrrhiza glabra (licorice) root extract, aloe barbadensis leaf juice powder, silica

Questions Or Comments? (Questions or comments?)

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)