Label: EPI FORMULA- belladonna, hyoscyamus niger, asterias rubens, calcarea carbonica, cicuta virosa, oenanthe crocata, cuprum metallicum spray
- NDC Code(s): 83027-0002-1
- Packager: Nutritional Specialties, Inc.
- 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 March 24, 2023
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- ACTIVE INGREDIENTS:
- PURPOSE:
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WARNINGS:
Professional Use Only
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
If condition worsens, seek medical attention.
KEEP OUT OF REACH OF CHILDREN
Do not use if tamper evident seal is broken or missing.
Store in a cool place after opening
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
EPI FORMULA
belladonna, hyoscyamus niger, asterias rubens, calcarea carbonica, cicuta virosa, oenanthe crocata, cuprum metallicum sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83027-0002 Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 4 [hp_X] in 1 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 4 [hp_X] in 1 mL ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS 8 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 1 mL CICUTA VIROSA ROOT (UNII: YEA9P21S8N) (CICUTA VIROSA ROOT - UNII:YEA9P21S8N) CICUTA VIROSA ROOT 10 [hp_X] in 1 mL OENANTHE CROCATA ROOT (UNII: 6FS6FK5S8N) (OENANTHE CROCATA ROOT - UNII:6FS6FK5S8N) OENANTHE CROCATA ROOT 10 [hp_X] in 1 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 12 [hp_X] in 1 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:83027-0002-1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/24/2023 Labeler - Nutritional Specialties, Inc. (032744609)