Otc - Active Ingredient
Active ingredient PurposeSalicylic Acid(0.5%)....................................Acne Medication
Salicylic Acid
FDA Label NDC 59779-078
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Salicylic Acid (NDC 59779-078). 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, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active ingredient PurposeSalicylic Acid (0.5%)..............................Acne Medication______________________________________Use for the management of acne
Otc - Keep Out Of Reach Of Children
_______________________________Keep out of reach of children. Incase of accidental ingestion, getmedical help or contact a Poison Control Center right away.
Indications & Usage
Use for the management of acne_______________________________Directions- Cleanse skin thoroughly beforeapplying medication- cover the entire affected area witha thin layer one to two times daily- because excessive drying of theskin may occur, start with oneapplication daily, then graduallyincrease to two or three timesdaily if needed or as directed by a doctor- if bothersome dryness or peelingoccurs, reduce application toonce a day or every other day
Warnings
Warnings For external use only. Using other topical acnemedications at the same time orimmediately following use of thisproduct may increase dryness orirritation of the skin. If this occurs,only one medication should be usedunless directed by a doctor.______________________________When using this product avoidcontact with eyes. If contact occurs,immediately flush with water._______________________________Keep out of reach of children. Incase of accidental ingestion, getmedical help or contact a Poison Control Center right away.
Dosage & Administration
Directions- Cleanse skin thoroughly beforeapplying medication- cover the entire affected area witha thin layer one to two times daily- because excessive drying of theskin may occur, start with oneapplication daily, then graduallyincrease to two or three timesdaily if needed or as directed by a doctor- if bothersome dryness or peelingoccurs, reduce application toonce a day or every other day
Inactive Ingredient
Inactive Ingredients Water,Dicaprylyl Ether, Glycerin,Dimethicone, Neopentyl GlycolDiethylhexanonate, Neopentyl GlycolDiisostearate, Aluminum Starch, Octenylsuccinate, Methyl Gluceth-20, Diacetyl Phosphate, Ceteth-10Phosphate, Cetearyl Alcohol,Menthyl Lactate, Steareth-20,Steareth-2, Fragrance, XanthanGum, Lecithin, Disodium EDTA, Sodium Hydroxide, MagnesiumAluminum Silicate, BHT
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