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

Purpose

Acne treatment

Description

Sulfur 10%


Medication Information

Warnings

For external use only

Purpose

Acne treatment

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
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

Description

Sulfur 10%

Use

for the treatment of acne

Section 51945-4

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



Sulfur 10%

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

Warnings

For external use only

Purpose

Acne treatment

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
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

Use

for the treatment of acne

Section 51945-4 (51945-4)

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



Sulfur 10%

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

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