FDA Label for Pleo San Acne
View Indications, Usage & Precautions
Pleo San Acne Product Label
The following document was submitted to the FDA by the labeler of this product Sanum Kehlbeck Gmbh & Co. Kg. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
For temporary relief of acne.
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
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