Salicylic Acid 0.5% Body Serum Lotion
FDA Label NDC 72208-321
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Deciem for the product Salicylic Acid 0.5% Body Serum (NDC 72208-321). 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 - questions, otc - purpose, warnings, dosage & administration, other safety information, inactive ingredient, otc - 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
Otc - Questions
Questions? Visit www.theordinary.com or call +1 800.513.6088
Otc - Purpose
Acne treatment
Warnings
Warnings
For external use only
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.
Dosage & Administration
Directions clean the skin thoroughly before applying
this product apply to body and rub in with hands if
needed allow the product to dry 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 or 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 avoid contact with eyes,
if contact occurs rinse thoroughly with water.
Other Safety Information
Other information
Patch testing prior to use is advised: Apply the product as
directed to a small area once a day for three days to test if you
are sensitive to this product
Inactive Ingredient
Inactive ingredients
Chlorphenesin, Glycerin, Isoceteth-20, Pentylene Glycol,
Phenoxyethanol, Sarcosine, Sodium Hydroxide, Water.
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.
Indications & Usage
Uses
For the treatment of acne.
Helps clear up acne blemishes and allows skin to heal.
Package Label.Principal Display Panel
* Please review the disclaimer below.