Label: CALLOUSED- allium sativum, anacardium orientale, calendula officinalis, capsicum annuum, ceanothus americanus, chamomilla, chelidonium majus, conium maculatum, kali carbonicum, lobelia cardinalis, mancinella, myristica sebifera, pinus sylvestris, flos, stigmata maidis, sepia, taraxacum officinale, thea sinensis liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 57955-2311-2 - Packager: King Bio 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 April 17, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS activeingredients: Allium sativum, Anacardium orientale, Calendula officinalis, Capsicum annuum, Ceanothus americanus, Chamomilla, Chelidonium majus, Conium maculatum, Kali carbonicum, Lobelia cardinalis, Mancinella, Myristica sebifera, Pinus sylvestris, flos, Stigmata maidis, Sepia, Taraxacum officinale, Thea sinensis. Equal volumes of each ingredient in 10X, 30X, 100X, LM1, LM2, LM3, LM5 potencies.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALLOUSED
allium sativum, anacardium orientale, calendula officinalis, capsicum annuum, ceanothus americanus, chamomilla, chelidonium majus, conium maculatum, kali carbonicum, lobelia cardinalis, mancinella, myristica sebifera, pinus sylvestris, flos, stigmata maidis, sepia, taraxacum officinale, thea sinensis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-2311 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC 10 [hp_X] in 59 mL SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 10 [hp_X] in 59 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 10 [hp_X] in 59 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 10 [hp_X] in 59 mL CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N) CEANOTHUS AMERICANUS LEAF 10 [hp_X] in 59 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 59 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 10 [hp_X] in 59 mL CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 10 [hp_X] in 59 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 10 [hp_X] in 59 mL LOBELIA CARDINALIS (UNII: GT0PJ8MB5R) (LOBELIA CARDINALIS - UNII:GT0PJ8MB5R) LOBELIA CARDINALIS 10 [hp_X] in 59 mL HIPPOMANE MANCINELLA FRUITING LEAFY TWIG (UNII: HU6EYI2I1W) (HIPPOMANE MANCINELLA FRUITING LEAFY TWIG - UNII:HU6EYI2I1W) HIPPOMANE MANCINELLA FRUITING LEAFY TWIG 10 [hp_X] in 59 mL VIROLA SEBIFERA RESIN (UNII: GHJ5XX5SGS) (VIROLA SEBIFERA RESIN - UNII:GHJ5XX5SGS) VIROLA SEBIFERA RESIN 10 [hp_X] in 59 mL PINUS SYLVESTRIS FLOWERING TOP (UNII: 2HEM73YI9I) (PINUS SYLVESTRIS FLOWERING TOP - UNII:2HEM73YI9I) PINUS SYLVESTRIS FLOWERING TOP 10 [hp_X] in 59 mL CORN SILK (UNII: 7D3VB244UX) (CORN SILK - UNII:7D3VB244UX) CORN SILK 10 [hp_X] in 59 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] in 59 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 10 [hp_X] in 59 mL GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF 10 [hp_X] 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:57955-2311-2 59 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/17/2014 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-2311)
