TRAUMA REMEDY (chamomilla, echinacea (angustifolia), hamamelis virginiana, hypericum perforatum, millefolium, calendula officina

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ), ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8), HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS), HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB), ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK), CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ
Available from:
Deseret Biologicals, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of symptoms related to minor injuries including bruises, contusions, lesions, sprains, and trauma following surgery.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration. For temporary relief of symptoms related to minor injuries including bruises, contusions, lesions, sprains, and trauma following surgery.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Authorization status:
unapproved homeopathic
Authorization number:
43742-1536-1

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

Deseret Biologicals, Inc.

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 Facts:

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, Bellis Perennis

6X, Rhus Tox 6X, 12X, 30X, Bryonia (Alba) 8X, Clematis Vitalba, Folia 8X, Hepar Sulphuris

Calcareum 8X, Ornithogalum Umbellatum 8X, Prunus Cerasifera, Flos 8X, Carbo Vegetabilis 12X.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to minor injuries including bruises, contusions, lesions,

sprains, and trauma following surgery.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by

the Food and Drug Administration.

WARNINGS:

Keep out of reach of children. In case of overdose, contact physician or a Poison Control Center right

away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or a Poison Control Center right

away.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician

for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to minor injuries including bruises, contusions, lesions,

sprains, and trauma following surgery.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by

the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-1536-1

HOMEOPATHIC

TRAUMA

REMEDY

1 FL OZ (30 ml)

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

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43742-1536

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MATRICARIA RECUTITA (UNII: G0 R4UBI2ZZ) (MATRICARIA CHAMOMILLA -

UNII:G0 R4UBI2ZZ)

MATRICARIA RECUTITA

3 [hp_X]

in 1 mL

ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) (ECHINACEA ANGUSTIFOLIA -

UNII:VB0 6 AV5US8 )

ECHINACEA ANGUSTIFOLIA

3 [hp_X]

in 1 mL

HAMAMELIS VIRGINIANA RO O T 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 PERFO RATUM (UNII: XK4IUX8 MNB) (HYPERICUM PERFORATUM -

UNII:XK4IUX8 MNB)

HYPERICUM PERFORATUM

3 [hp_X]

in 1 mL

ACHILLEA MILLEFO LIUM (UNII: 2FXJ6 SW4PK) (ACHILLEA MILLEFOLIUM -

UNII:2FXJ6 SW4PK)

ACHILLEA MILLEFOLIUM

3 [hp_X]

in 1 mL

CALENDULA O FFICINALIS FLO WERING TO P (UNII: 18 E7415PXQ) (CALENDULA

OFFICINALIS FLOWERING TOP - UNII:18 E7415PXQ)

CALENDULA OFFICINALIS

FLOWERING TOP

4 [hp_X]

in 1 mL

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

4 [hp_X]

in 1 mL

BELLIS PERENNIS (UNII: 2HU33I0 3UY) (BELLIS PERENNIS - UNII:2HU33I0 3UY)

BELLIS PERENNIS

6 [hp_X]

in 1 mL

TO XICO DENDRO N PUBESCENS LEAF (UNII: 6 IO18 2RP7A) (TOXICODENDRON

PUBESCENS LEAF - UNII:6 IO18 2RP7A)

TOXICODENDRON

PUBESCENS LEAF

6 [hp_X]

in 1 mL

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT -

UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

8 [hp_X]

in 1 mL

CLEMATIS VITALBA TO P (UNII: 49 0 F0 0 0 9 OP) (CLEMATIS VITALBA PRE-

FLOWERING TOP - UNII:49 0 F0 0 0 9 OP)

CLEMATIS VITALBA TOP

8 [hp_X]

in 1 mL

CALCIUM SULFIDE (UNII: 1MBW0 7J51Q) (CALCIUM SULFIDE - UNII:1MBW0 7J51Q)

CALCIUM SULFIDE

8 [hp_X]

in 1 mL

O RNITHO GALUM UMBELLATUM (UNII: 9 NS3M2Y78 S) (ORNITHOGALUM

UMBELLATUM - UNII:9 NS3M2Y78 S)

ORNITHOGALUM

UMBELLATUM

8 [hp_X]

in 1 mL

PRUNUS CERASIFERA FLO WER (UNII: 0 KD7R0 9 EAS) (PRUNUS CERASIFERA

FLOWER - UNII:0 KD7R0 9 EAS)

PRUNUS CERASIFERA

FLOWER

8 [hp_X]

in 1 mL

ACTIVATED CHARCO AL (UNII: 2P3VWU3H10 ) (ACTIVATED CHARCOAL -

UNII:2P3VWU3H10 )

ACTIVATED CHARCOAL

12 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:43742-

1536 -1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /22/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 8 /22/20 19

Labeler -

Deseret Biologicals, Inc. (940741853)

Registrant -

Apotheca Company (844330915)

Deseret Biologicals, Inc.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(43742-1536 ) , api manufacture(43742-1536 ) , label(43742-1536 ) , pack(43742-

1536 )

Revised: 8/2019

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