Otc - Active Ingredient
Active Ingredients
Salicylic Acid 0.5% w/w
The following Structured Product Label (SPL) was submitted to the FDA by Srl Enterprises Llc for the product Clearsynergy (NDC 71617-100). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients
Salicylic Acid 0.5% w/w
Purpose: Acne Treatment
Uses: For the treatment of acne
Warnings:
For external use only
When using this product
Avoid contact with eyes and mouth.
If contact occurs, rinse thoroughly
with water. Skin irritation and dryness
is more likely to occur if you use
another topical acen medication at
the same time. If irritation occurs,
only use one topical acne medication
at a time. Limit use to face and neck.
Keep out of reach of children:
If product is swallowed, get medical
help or contact a Poison Control
Center right away.
Directions:
Clean the skin thoroughly before
applying e product.
•Cover the entire 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, Sodium PCA, Ammonium Lauryl
Sulfate, Succinic Acid, Phospheric Acid.
Other information:
•Store in a cool, dry place
•Do not freeze
Questions or Comments?
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