Label: PLEO CAL- giant puffball solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-0111-1 - 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 September 28, 2009
If you are a consumer or patient please visit this version.
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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™ 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 Box
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INGREDIENTS AND APPEARANCE
PLEO CAL
giant puffball solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-0111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GIANT PUFFBALL (UNII: I6839Y031A) (GIANT PUFFBALL - UNII:I6839Y031A) GIANT PUFFBALL 3 [hp_X] in 10 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-0111-1 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 08/19/1998 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
