sulfur spot treatment

sulfur spot treatment
SPL v4
SPL
SPL Set ID 921e948d-a8c7-4527-9257-4b91dee8fcff
Route
topical
Published
Effective Date 2021-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sulfur (60 mg)
Inactive Ingredients
butylene glycol acacia carbomer homopolymer, unspecified type phenoxyethanol water allantoin benzyl alcohol glycerin caprylhydroxamic acid sodium hydroxide ethylhexylglycerin palmitoyl tripeptide-8

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-01-08

Purpose

Acne Treatment

Description

Sulfur 6%


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
Other Information

Store at room temperature. Keep away from heat or direct sunlight.

Inactive Ingredients

Aqua (Water), Butylene Glycol, Acacia Senegal Gum, Carbomer, Phenoxyethanol, Bisabolol (L-alpha), Allantoin, Benzyl Alcohol, Glycerin, Caprylhydroxamic Acid, Dextran, Sodium Hydroxide, Ethylhexylglycerin, Palmitoyl Tripeptide-8.

Description

Sulfur 6%

Use

for the treatment of acne

Do Not Use
  • on broken skin
  • on large areas of skin
Active Ingredient

Sulfur 6%

Questions Or Comments?

1-866-477-3077

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
Package Labeling:70707 440 04

Package Labeling:70707 440 15

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
Other Information (Other information)

Store at room temperature. Keep away from heat or direct sunlight.

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Butylene Glycol, Acacia Senegal Gum, Carbomer, Phenoxyethanol, Bisabolol (L-alpha), Allantoin, Benzyl Alcohol, Glycerin, Caprylhydroxamic Acid, Dextran, Sodium Hydroxide, Ethylhexylglycerin, Palmitoyl Tripeptide-8.

Use

for the treatment of acne

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

Sulfur 6%

Questions Or Comments? (Questions or Comments?)

1-866-477-3077

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
Package Labeling:70707 440 04 (Package Labeling:70707-440-04)

Package Labeling:70707 440 15 (Package Labeling:70707-440-15)

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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