Label: TRAUMA REMEDY (chamomilla, echinacea (angustifolia), hamamelis virginiana, hypericum perforatum, millefolium, calendula officinalis, arnica montana, bellis perennis, rhus tox, bryonia- alba, clematis vitalba, folia, hepar sulphuris calcareum, ornithogalum umbellatum, prunus cerasifera, flos, carbo vegetabilis liquid
- NDC Code(s): 43742-1536-1
- Packager: Deseret Biologicals, Inc.
- Category: HUMAN OTC DRUG LABEL
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 7, 2024
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ACTIVE INGREDIENTS:
Arnica Montana 4X, 12X, 30X, 200X, Bellis Perennis 6X, Bryonia (Alba) 8X, Calendula Officinalis 4X, Carbo Vegetabilis 12X, Chamomilla 3X, Clematis Vitalba, Folia 8X, Echinacea (Angustifolia) 3X, Hamamelis Virginiana 3X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 3X, Millefolium 3X, 6X, Ornithogalum Umbellatum 8X, Prunus Cerasifera, Flos 8X, Rhus Tox 6X, 12X, 30X.
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PURPOSE:
Arnica Montana – Trauma Following Surgery, Bellis Perennis - Injuries, Bryonia (Alba) - Bruises, Calendula Officinalis - Contusions, Carbo Vegetabilis - Lesions, Chamomilla - Sprains, Clematis Vitalba, Folia - Lesions, Echinacea (Angustifolia) – Trauma Following Surgery, Hamamelis Virginiana - Injuries, Hepar Sulphuris Calcareum - Bruises, Hypericum Perforatum - Contusions, Millefolium - Lesions, Ornithogalum Umbellatum – Trauma Following Surgery, Prunus Cerasifera, Flos - Lesions, Rhus Tox - Bruises
- USES:
- WARNINGS:
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- DIRECTIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
TRAUMA REMEDY
chamomilla, echinacea (angustifolia), hamamelis virginiana, hypericum perforatum, millefolium, calendula officinalis, arnica montana, bellis perennis, rhus tox, bryonia (alba), clematis vitalba, folia, hepar sulphuris calcareum, ornithogalum umbellatum, prunus cerasifera, flos, carbo vegetabilis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1536 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 3 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_X] in 1 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 3 [hp_X] in 1 mL ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM WHOLE 3 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 4 [hp_X] in 1 mL ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 4 [hp_X] in 1 mL BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE 6 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 8 [hp_X] in 1 mL CLEMATIS VITALBA TOP (UNII: 490F0009OP) (CLEMATIS VITALBA PRE-FLOWERING TOP - UNII:490F0009OP) CLEMATIS VITALBA TOP 8 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] in 1 mL ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM WHOLE 8 [hp_X] in 1 mL PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER 8 [hp_X] in 1 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 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:43742-1536-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/22/2019 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1536) , api manufacture(43742-1536) , label(43742-1536) , pack(43742-1536)
