NDC | 53852-0008-2 |
Set ID | 2aff35e2-4c66-4b18-89fe-f6c3e2f91cfc |
Category | HUMAN OTC DRUG LABEL |
Packager | Living Well Remedies, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PURPOSE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEM REMEDY
amyl nitrosum, calcarea carbonica, cimicifuga racemosa, ferrum metallicum, sanguinaria canadensis, sepia liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53852-0008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMYL NITRITE (UNII: 22T8Z09XAK) (AMYL NITRITE - UNII:22T8Z09XAK) AMYL NITRITE 10 [hp_C] in 59 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_C] in 59 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 10 [hp_C] in 59 mL IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 10 [hp_C] in 59 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 10 [hp_C] in 59 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_C] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53852-0008-2 59 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/16/2014 Labeler - Living Well Remedies, LLC (022609201) Registrant - Living Well Remedies, LLC (022609201)