Active Ingredients
Salicylic Acid 2%
Acne Back Chest Treatment
FDA Label NDC 84262-012
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 Back Chest Treatment (NDC 84262-012). 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, directions, flammable, when using this product, keep out of reach of children., 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.
Directions
- Spray directly onto cleansed affected areas of the back, shoulders and chest by holding 3 to 6 inches away from the skin one to three times daily.
- Pump works upside down for optimal application.
- Let dry prior to putting on clothes.
- Beacuase 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.
Flammable
Keep away from fire or flame.
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.
- avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
- spray in a well ventilated area. Do not inhale.
Keep Out Of Reach Of Children.
If swallowed get medical help or contact a Poison Control Center right away.
Inactive Ingredients
AQUA (WATER), ALCOHOL DENAT., METHYLPROPANEDIOL, GLUCONOLACTONE, POLYSORBATE 20, POTASSIUM SORBATE, SODIUM GLUCONATE, SODIUM BENZOATE, CITRIC ACID, GLYCERIN, HIBISCUS SABDARIFFA FLOWER EXTRACT, CENTELLA ASIATICA (GOTU KOLA) LEAF EXTRACT, CAMELLA SINENSIS (WHITE TEA) LEAF EXTRACT, CAMELLA OLEFERA (GREEN TEA) LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, SODIUM HYDROXIDE
Package Label.Principal Display Panel
GLYTONE
ACNE BACK & CHEST TREATMENT SPRAY
ACNE THERAPY
2% SALICYLIC ACID ACNE MEDICATION
GLUCONOLACTONE (PHA)
ALOE
240 mL / 8.0 FL. OZ.
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