Otc - Purpose
For temporary relief of acne.
Pleo San Acne
FDA Label NDC 60681-3601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanum Kehlbeck Gmbh & Co. Kg for the product Pleo San Acne (NDC 60681-3601). 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 - purpose, inactive ingredient, tamper evident, dosage, warning, principal display panel - 10 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
10 mL Propionibacterium acnes 6X in a base of purified water.
Tamper Evident
Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.
Dosage
1-2 × daily 5-10 drops.
Warning
If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.
Principal Display Panel - 10 Ml Label
Pleo™ San ACNE DROPS 6X
Homeopathic Medicine
Indications: For temporary relief of acne.
0.34 fl oz (10 mL)
DOSAGE: 1–2 × daily 5–10 drops. WARNING: If symptoms persist more than a few days,
contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby,
seek the advice of a health care professional before using this product. Keep this and
all medications out of reach of children. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Protect from
light and heat. TAMPER EVIDENT: Do not use this product if tamper-evident seal on
base of bottle cap is missing or broken. INGREDIENTS: 10 mL Propionibacterium acnes
6X in a base of purified water.
Rev. 06/2009
Principal Display Panel (10 mL Label)
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