Active Ingredients
Resorcinol 2%
Sulfur 8%
Acne Tinted Spot Treatment
FDA Label NDC 84262-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glytone Llc for the product Acne Tinted Spot Treatment (NDC 84262-023). 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 active ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor, keep out of reach of children, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Use
For the treatment of acne.
- Dries and clears acne blemishes and allows skin to heal.
- Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads.
- Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
Warnings
For external use only.
When Using 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 swallowed, ge medical help or contact a Poison Control Center right away.
Do Not Use
on
- broken skin
- large areas of the skin
Directions
- Cleanse the skin thoroughly before applying this product.
- Cover the 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 to 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.
Inactive Ingredients
WATER, PROPYLENE GLYCOL. ALCOHOL DENAT., POLYSORBATE 20, CAPRYLIC/CAPRIC TRIGLYCERIDE, MAGNESIUM ALUMINUM SILICATE, SODIUM STEAROYL, GLUTAMATE, CETEARYL ALCOHOL, GLYCERYL SEARATE, POLYSORBATE 60, CHLOROXYLENOL, ETHYLHEXYLGLYCERIN, FRAGRANCE, PHENOXYETHANOL, POLYGLYCERYL-6 PALMITATE.SUCCINATE, XANTHAN GUM, IRON OXIDES, TITANIUM DIOXIDE
Principal Display Panel
GLYTONE
ACNE TINTED SPOT TREATMENT
ACNE THERAPY
2% RESORCINOL
8% SULFURE
30ML / 1 FL. OZ.
* Please review the disclaimer below.
