Indications
For temporary relief of arthritis pain and stiffness.
Pleo Art A
FDA Label NDC 60681-0301
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 Art A (NDC 60681-0301). 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 indications, 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
Use this product only if tamper-evident strip on base of bottle cap is intact.
Dosage
1–3 x weekly 2–5 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® Art "A" DROPS 6X
Homeopathic Analgesic Medicine
Indications: For temporary relief of arthritis pain and stiffness.
0.34 fl oz (10 mL)
DOSAGE: 1–3 x weekly 2–5 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 the 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 Propioni-
bacterium acnes 6X in a base of purified water.
Rev. 09/2010
Principal Display Panel (10 mL Label)
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