FDA Label for Acne Tinted Spot Treatment
View Indications, Usage & Precautions
Acne Tinted Spot Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Glytone, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage
For the treatment of acne.
Dries and helps clear up acne pimples and blackheads.
Helps prevent new acne blemishes from forming
Warnings And Precautions
For external use only
Do not use
• on broken skin
• on large areas of the body
When using this product
• avoid contact with eyes. If contact occurs, rinse thoroughly with water
• apply only to areas with acne
• skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time
Stop use and ask a doctor if
• skin irritation becomes severe
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Clean the skin thoroughly before applying this product
Cover the entire affected area with a thin layer 1 to 3 times daily
Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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
• Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer 1 to 3 times daily
• Because excessive drying may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day
Inactive Ingredient
Water, Cyclopentasiloxane, Isocetyl Stearate, Polysorbate 60, Sorbitan Stearate, Steareth-2, PEG-100 Stearate, Steareth-21, Glycerin, Glyceryl Stearate, Butylene Glycol, Cetearyl Alcohol, Bentonite, Dimethicone Crosspolymer, Diazolidinyl Urea, Sodium Hydroxide, Methylparaben, Propylparaben, Fragrance (Parfum), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)
Otc - Active Ingredient
Sulfur 8% – Acne treatment
Resorcinol 2% – Acne treatment
Warnings
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Other Safety Information
• Store at room temperature
• Avoid excessive heat and direct sunlight
Recent Major Changes
Updated section type
Otc - 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.
Otc - Purpose
Purpose
Acne treatment
Package Label.Principal Display Panel
* Please review the disclaimer below.
