Otc - Active Ingredient
Active Ingredients
Sulfur 4%
Resorcinol 2%
Utiliderm Acne Control
FDA Label NDC 71493-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sante Naturelle (a.g.) Ltee for the product Utiliderm Acne Control (NDC 71493-001). 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 - do not use, otc - when using, otc - stop use, 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 - Purpose
Purpose
acne medication
acne medication
Indications & Usage
Use
for the treatment of acne
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use on
■ broken skin ■ large areas of the skin
Otc - When Using
When using this product
■ apply only to areas with acne ■ rinse eyes 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.
Otc - Stop Use
Stop use and ask a doctor if skin irritation occurs
or gets worse.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get
medical help or contact Poison Control Center right away.
Dosage & Administration
Directions
■ clean the skin thoroughly before applying this 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 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.
Information For Patients
Other information
■ keep tightly closed ■ keep away from heat
■ Report serious adverse reaction to:
c/o Report Reaction, LLC, P.O. Box 22,
Plainsboro, New Jersey 08536-0222
Inactive Ingredient
Inactive ingredients
Benzalkonium chloride, bergamot essential oil,
carbomer U-10, chitosan, Melaleuca alternifolia leaf
essential oil, Nigella sativa seed oil, olive oil, Origanum
vulgare whole plant essential oil, polysorbate 80,
sorbitan.
Otc - Questions
Questions or comments?
Call toll free 1-800-781-7723.
Weekdays from 9 AM - 4 PM, Eastern time.
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