spot correction

spot correction
SPL v3
SPL
SPL Set ID 45ec40ff-7134-085b-e054-00144ff8d46c
Route
topical
Published
Effective Date 2017-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sulfur (30 mg)
Inactive Ingredients
4-tert-butylcyclohexanol acacia arginine chondrus crispus carrageenan citrus maxima fruit rind oil epilobium angustifolium flowering top lactic acid leuconostoc/radish root ferment filtrate tea tree oil niacinamide pentylene glycol sodium hydroxide water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-01-11

Purpose

Acne treatment ointment

Description

Colloidal Sulfur (3%)


Medication Information

Warnings

For external use only

Uses
  • treats acne
  • helps prevent new pimples
  • clears up most acne pimples
Purpose

Acne treatment ointment

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 controlled room temperature (59° - 86°F)
Inactive Ingredients

4-t-Butylcyclohexanol, Acacia Senegal Gum, Arginine, Chondrus Crispus (Carrageenan), Citrus Grandis (Grapefruit) Peel Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Lactic Acid, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, Pentylene Glycol, Rice Ferment (Sake) Filtrate, Sodium Hydroxide, Water (Aqua), Xanthan Gum

Description

Colloidal Sulfur (3%)

Do Not Use On:
  • broken skin
  • large areas of the body
Package Labeling:

Active Ingredients 

Colloidal Sulfur (3%)

Questions Or Comments?

Call 1.800.932.9873

When Applying This Product
  • apply only to areas with acne
  • rinse right away with water if it gets in eyes
  • 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.
Stop Use and Ask A Doctor If
  • skin irritation occurs or gets worse
Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses
  • treats acne
  • helps prevent new pimples
  • clears up most acne pimples
Purpose

Acne treatment ointment

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 controlled room temperature (59° - 86°F)
Inactive Ingredients

4-t-Butylcyclohexanol, Acacia Senegal Gum, Arginine, Chondrus Crispus (Carrageenan), Citrus Grandis (Grapefruit) Peel Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Lactic Acid, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, Pentylene Glycol, Rice Ferment (Sake) Filtrate, Sodium Hydroxide, Water (Aqua), Xanthan Gum

Do Not Use On: (Do not use on:)
  • broken skin
  • large areas of the body
Package Labeling:

Active Ingredients 

Colloidal Sulfur (3%)

Questions Or Comments? (Questions or Comments?)

Call 1.800.932.9873

When Applying This Product (When applying this product)
  • apply only to areas with acne
  • rinse right away with water if it gets in eyes
  • 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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin irritation occurs or gets worse
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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