Bioactive Services USA, LLC / Herstat Inc.
10 extracted findings
FDA source excerpt, selected passage
On product label: “Genital Sore Treatment”
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
On product label: “Genital Sore Treatment”
Source passage selected by the model
02
“Herstat GST provides rapid and targeted relief of genital sores at tingle, blister or scab, getting to work from 1st use at any stage of an outbreak”
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03
“The formula is dual action, designed to provide effective relief of symptoms (itching, pain, irritation) and aid healing of skin during outbreaks by calming inflammation and balancing PH”
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04
“Dr Sosnowski’s Herstat GST is formulated to provide effective relief from the symptoms of genital sores.”
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05
“The carefully balanced formula of GST helps to soothe and calm the symptoms of genital sores and provides temporary relief of pain, itching and inflammation.”
Source passage selected by the model
06
“Effective for the treatment of genital sores”
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07
“Herstat GST provides rapid, targeted relief from the symptoms of genital sores.”
Source passage selected by the model
08
“[P]rovides targeted pain relief . . . soothing relief to calm the discomfort associated with genital sores.” . . .
Source passage selected by the model
09
“[A]nalgesic action . . . penetrate deep into the epidermis.”
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10
No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.