Active Ingredient
Sulfur 3.0%
The following Structured Product Label (SPL) was submitted to the FDA by Owen Biosciences Inc. for the product Slmd Silver Sulfur Acne Cream (NDC 59958-407). 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 ingredient, purpose, use, warningsfor external use only., directions, keep out of reach of children., sulfur carton.jpg, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Sulfur 3.0%
Acne Treatment
Use for the management of acne
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.
•apply only to areas with acne
• avoid contact with the eyes, lips, and mouth
Do not use on:
• broken skin
• large areas of the skin
Stop use and ask a doctor if
irriatation becomes servere.
Keep out of reach of children.
If swallowed, get medical help or
contact a Poison Control Center
right away
• 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 applicagtion 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
• Sensitivity Test for a New User:
Apply product sparingly to one or
two small affected areas during
the first 3 days. If no discomfort
occurs, follow the directions
stated above.
If swallowed, get medical help or
contact a Poison Control Center
right away
Sulfur Carton.jpg
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