Otc - Active Ingredient
SULFUR 10%................................................................Acne Treatment
Goodbye Acne Therapeutic Sulfur Mask Paste
FDA Label NDC 54031-107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peter Thomas Roth, Llc for the product Goodbye Acne Therapeutic Sulfur Mask (NDC 54031-107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - when using, otc - do not use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
USES
- For the treatment and management of acne.
- Clears up active acne blemishes and blackheads.
- Helps to prevent new acne blemishes and blackheads.
Warnings
WARNINGS
For external use only.
Otc - When Using
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
Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use abd consult a doctor.
Otc - Do Not Use
Do not use on
- Broken skin
- Large areas of the skin
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Clean skin. Apply to affected areas of face, chest and back.
- Allow mask to dry for 5-10 minutes and rinse thoroughly with water to remove.
- Pat dry.
- Apply 2-3 times per week.
- If bothersome dryness or peeling occurs, reduce frequency of application
- Mask may dry out over time, add a few drops of water if needed.
Inactive Ingredient
Inactive Ingredients
Water/Aqua/eau, Propylene Glycol, Glycerin, Bentonite, Kaolin, Aloe Barbadensis Leaf Juice, Titanium Dioxide, Zinc Oxide, Phenoxyethanol, Carbomer, Polysorbate 20, Potassium Sorbate, Sodium benzoate, triethoxycaprylylsilane, Fragrane/Parfum, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin.
Otc - Questions
Questions or Comments?
Call toll free 1-800-PTR-SKIN (787-7546)
Otc - Purpose
Sulfur 10%..................................................................................Acne treatment
Package Label.Principal Display Panel
Carton Image (1742230488620 696ac0b6 9a5b 4745 9be8 4764b090c983 1)
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