Indications
For temporary relief of painful skin rashes.
Pleo Grif
FDA Label NDC 60681-0123
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 Grif (NDC 60681-0123). 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
10 mL Grifola frondosa 5X 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.
Dosage
5–10 drops, once 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™ Grif DROPS 5X
Homeopathic Medicine
Indications: For temporary relief of painful skin rashes.
0.34 fl oz (10 mL)
DOSAGE: 5–10 drops, once 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 Grifola frondosa 5X in a base of purified water.
Rev. 06/2009
Principal Display Panel (10 mL Label)
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