Otc - Purpose
Homeopathic Ophthalmic Demulcent Medicine
Pleo Muc
FDA Label NDC 60681-1802
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 Muc (NDC 60681-1802). 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, indications, active ingredient per 0.17 fl oz/5 ml, inactive ingredients, tamper evident, dosage, warnings, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications
For temporary relief of irritated and dry eyes.
Active Ingredient Per 0.17 Fl Oz/5 Ml
5 g Mucor racemosus 5X.
Inactive Ingredients
Isotonic sodium chloride solution, chlorhexidine diacetate.
Tamper Evident
Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.
Dosage
1 drop, twice daily, into affected eye(s).
Warnings
To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Discard 30 days after opening.
Otc - Do Not Use
Do not use if liquid changes color or becomes cloudy.
Otc - Stop Use
Stop use and ask a doctor if you feel eye pain, vision changes, continued redness or irritation of the eye, or if condition worsens or lasts for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of children's reach. In case of ingestion, seek professional help directly or contact a Poison Control Center.
Other
Manufactured by:
SANUM-Kehlbeck
GmbH & Co. KG,
Hoya, Germany
Distributed by:
SANUM USA Corp.,
1465 Slater Road,
Ferndale, WA 98248
Principal Display Panel - 5 Ml Bottle Carton
Pleo® Muc
EYE DROPS
5X
Homeopathic
Ophthalmic
Demulcent
Medicine
The original
SANUM®
brand remedies
Indications: For
temporary relief
of irritated
and dry eyes.
ORIGINAL ENDERLEIN
0.17 fl oz
(5 mL)
Principal Display Panel (5 mL Bottle Carton)
* Please review the disclaimer below.
