Label: PLEO GRIF- maitake solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-0123-1 - Packager: Sanum Kehlbeck GmbH & Co. KG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated October 7, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Indications
- INGREDIENTS
- Tamper Evident
- DOSAGE
- WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
PLEO GRIF
maitake solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-0123 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength maitake (UNII: A1U5YJI0Z8) (maitake - UNII:A1U5YJI0Z8) maitake 5 [hp_X] in 10 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-0123-1 1 in 1 CARTON 1 10 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/02/1998 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)