Indications
To reduce bleeding from cuts and scrapes.
Pleo Cal
FDA Label NDC 60681-0111
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 Cal (NDC 60681-0111). 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, ingredients, tamper evident, dosage, warning, principal display panel - 10 ml label, principal display panel - 10 ml box, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
10 mL Calvatia gigantea 3X in a base of purified water, ethanol (70%).
Tamper Evident
Use this product only if tamper evident strip has not been broken or removed from base of cap.
Dosage
5–10 drops, 1–3 times daily, before mealtime.
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™ Cal DROPS 3X
Homeopathic Medicine
Indications: To reduce bleeding from cuts and scrapes.
0.34 fl oz (10 mL)
DOSAGE: 5–10 drops, 1–3 times daily before mealtime. 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 Calvatia gigantea
3X in a base of purified water, ethanol (70%).
Rev. 06/2009
Principal Display Panel (10 mL Label)
Principal Display Panel - 10 Ml Box
Pleo™ Cal
DROPS 3X
Homeopathic
Medicine
Indications: To
reduce bleeding
from cuts and
scrapes.
0.34 fl oz
(10 mL)
Principal Display Panel (10 mL Box)
* Please review the disclaimer below.
