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

Description

Colloidal Sulfur (3%)

Purpose

Acne treatment ointment


Medication Information

Purpose

Acne treatment ointment

Description

Colloidal Sulfur (3%)

Uses
  • treats acne
  • helps prevent new pimples
  • clears up most acne pimples
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 body
Other Information
  • store at controlled room temperature (59° - 86°F)
Package Labeling:

Active Ingredients 

Colloidal Sulfur (3%)

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

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

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

Acne treatment ointment

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 body
Other Information
  • store at controlled room temperature (59° - 86°F)
Package Labeling:

Active Ingredients 

Colloidal Sulfur (3%)

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

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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