Label: TRAUMA RELIEF (chamomilla, echinacea (angustifolia), hamamelis virginiana, hypericum perforatum, millefolium, calendula officinalis, arnica montana, belladonna, bellis perennis, clematis vitalba, flos, helianthemum nummularium, flos, impatiens glandulifera, flos, ornithogalum umbellatum, flos, prunus cerasifera, flos, symphytum officinale, rhus tox, bryonia- alba, hepar sulphuris calcareum, carbo vegetabilis liquid
- NDC Code(s): 43742-1333-1
- Packager: Deseret Biologicals, 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 December 7, 2018
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ACTIVE INGREDIENTS:
Chamomilla 3X, Echinacea (Angustifolia) 3X, Hamamelis Virginiana 3X, Hypericum Perforatum 3X, Millefolium 3X, 6X, Calendula Officinalis 4X, Arnica Montana 4X, 12X, 30X, 200X, Belladonna 6X, Bellis Perennis 6X, Clematis Vitalba, Flos 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Symphytum Officinale 6X, Rhus Tox 6X, 12X, 30X, Bryonia (Alba) 4X, Hepar Sulphuris Calcareum 8X, Carbo Vegetabilis 12X.
- HOMEOPATHIC INDICATIONS:
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WARNINGS:
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, seek advice of a health professional before use.
Do not use if seal is broken or missing.
For external use only, not for oral use.
Do not expose to extreme heat.
- KEEP OUT OF REACH OF CHILDREN:
- SUGGESTED APPLICATION:
- HOMEOPATHIC INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
TRAUMA RELIEF
chamomilla, echinacea (angustifolia), hamamelis virginiana, hypericum perforatum, millefolium, calendula officinalis, arnica montana, belladonna, bellis perennis, clematis vitalba, flos, helianthemum nummularium, flos, impatiens glandulifera, flos, ornithogalum umbellatum, flos, prunus cerasifera, flos, symphytum officinale, rhus tox, bryonia (alba), hepar sulphuris calcareum, carbo vegetabilis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 3 [hp_X] in 1 g ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [hp_X] in 1 g 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 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X] in 1 g ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 3 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 4 [hp_X] in 1 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 4 [hp_X] in 1 g ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_X] in 1 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 6 [hp_X] in 1 g HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER 6 [hp_X] in 1 g IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER 6 [hp_X] in 1 g ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B) ORNITHOGALUM UMBELLATUM FLOWERING TOP 6 [hp_X] in 1 g PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER 6 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] in 1 g BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 8 [hp_X] in 1 g CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] in 1 g ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ARGININE (UNII: 94ZLA3W45F) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) BENZYL ALCOHOL (UNII: LKG8494WBH) DEHYDROACETIC ACID (UNII: 2KAG279R6R) GLYCINE (UNII: TE7660XO1C) ASPARTIC ACID (UNII: 30KYC7MIAI) HYALURONIC ACID (UNII: S270N0TRQY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43742-1333-1 126 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/07/2018 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1333) , api manufacture(43742-1333) , label(43742-1333) , pack(43742-1333)