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First Aid Mind and Body

First Aid Mind and Body

Approved
Approval ID

0df2c9ab-229d-413f-8670-3fc53dcb9eab

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 2025

Manufacturers
FDA

King Bio Inc.

DUNS: 617901350

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus tox, Sulphur, Symphytum officinale, Trifolium pratense, Veratrum album

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-9004
Product Classification
G
Generic Name
Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus tox, Sulphur, Symphytum officinale, Trifolium pratense, Veratrum album
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2025
FDA Product Classification

INGREDIENTS (38)

ACONITUM NAPELLUS WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: U0NQ8555JD
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 10 [hp_X] in 59 mL
Code: S7V92P67HO
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 10 [hp_X] in 59 mL
Code: WQZ3G9PF0H
Classification: ACTIB
BELLIS PERENNIS WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: 2HU33I03UY
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: T7J046YI2B
Classification: ACTIB
MATRICARIA CHAMOMILLA WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: G0R4UBI2ZZ
Classification: ACTIB
HELIANTHEMUM CANADENSEActive
Quantity: 10 [hp_X] in 59 mL
Code: 46G3W789Q3
Classification: ACTIB
CLEMATIS RECTA FLOWERING TOPActive
Quantity: 10 [hp_X] in 59 mL
Code: 396421SP9F
Classification: ACTIB
CLEMATIS VITALBA FLOWERActive
Quantity: 10 [hp_X] in 59 mL
Code: 7SCP4N87CI
Classification: ACTIB
FERROSOFERRIC PHOSPHATEActive
Quantity: 10 [hp_X] in 59 mL
Code: 91GQH8I5F7
Classification: ACTIB
HISTAMINE DIHYDROCHLORIDEActive
Quantity: 10 [hp_X] in 59 mL
Code: 3POA0Q644U
Classification: ACTIB
STRYCHNOS IGNATII SEEDActive
Quantity: 10 [hp_X] in 59 mL
Code: 1NM3M2487K
Classification: ACTIB
IMPATIENS GLANDULIFERA FLOWERActive
Quantity: 10 [hp_X] in 59 mL
Code: AJU5O1A5ZV
Classification: ACTIB
ORNITHOGALUM UMBELLATUM FLOWERING TOPActive
Quantity: 10 [hp_X] in 59 mL
Code: CZD6M4PY4B
Classification: ACTIB
PHOSPHORUSActive
Quantity: 10 [hp_X] in 59 mL
Code: 27YLU75U4W
Classification: ACTIB
PRUNUS CERASIFERA FLOWERActive
Quantity: 10 [hp_X] in 59 mL
Code: 0KD7R09EAS
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 10 [hp_X] in 59 mL
Code: 6IO182RP7A
Classification: ACTIB
SULFURActive
Quantity: 10 [hp_X] in 59 mL
Code: 70FD1KFU70
Classification: ACTIB
COMFREY ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: M9VVZ08EKQ
Classification: ACTIB
VERATRUM ALBUM ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: QNS6W5US1Z
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0T
Classification: IACT
ORANGE PEELInactive
Code: TI9T76XD44
Classification: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4Y
Classification: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWR
Classification: IACT
CARYA OVATA BARKInactive
Code: X765CF609L
Classification: IACT
STEVIOLInactive
Code: 4741LYX6RT
Classification: IACT
APIS MELLIFERAActive
Quantity: 10 [hp_X] in 59 mL
Code: 7S82P3R43Z
Classification: ACTIB
ARNICA MONTANA WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: O80TY208ZW
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 10 [hp_X] in 59 mL
Code: 18E7415PXQ
Classification: ACTIB
Hypericum perforatumActive
Quantity: 10 [hp_X] in 59 mL
Code: XK4IUX8MNB
Classification: ACTIB
PASSIFLORA INCARNATA FLOWERING TOPActive
Quantity: 10 [hp_X] in 59 mL
Code: CLF5YFS11O
Classification: ACTIB
TRIFOLIUM PRATENSE FLOWERActive
Quantity: 10 [hp_X] in 59 mL
Code: 4JS0838828
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/11/2023

image description Frist Aid Mind and Body.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/11/2023

Uses

Temporary relieves symptoms due to mental, emotional or physical stress:

  • nervous tension
  • body aches
  • restlessness
  • irritability
  • oversensitivity
  • sleeplessness

As per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.

Reference image: Frist Aid Mind and Body.jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/11/2023

Directions

Initially, depress pump until
primed.

Spray one dose directly into
mouth.

Adults: 3 sprays 3 times per
day.

Children ages 6-12: 2 sprays 3 times per day.

Consult a physician for use in children under 6 years of age.

Use additionally as needed, up to 6 times per day.

Reference image: Frist Aid Mind and Body.jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/11/2023

Other information

Tamper resistant for your protection.

Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Reference image: Frist Aid Mind and Body.jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/11/2023

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image: Frist Aid Mind and Body.jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/11/2023

Active ingredients

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus tox, Sulphur, Symphytum officinale, Trifolium pratense, Veratrum album.

Reference image: Frist Aid Mind and Body.jpg

WARNINGS SECTION

LOINC: 34071-1Updated: 4/11/2023

Warnings

Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.

If pregnant or breast-feeding, ask a healthcare professional
before use.
Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image: Frist Aid Mind and Body.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/11/2023

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image: Frist Aid Mind and Body.jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/11/2023

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Aconitum napellus....................emotional and physical stress

Apis mellifica.........................................burns, pain, apathy

Arnica montana.........................aches, pains, oversensitivity

Arsenicum album................tension, restlessness, exhaustion

Belladonna.............................agitation, excited metal states

Bellis perennis.............injuries, sore muscles, bruises, aching

Bryonia.....................................aches, weakness, irritability

Calendula officinalis.............skin injuries, burns, nervousness

Chamomilla..............................mental and emotional stress

Cistus canadensis...............sleeplessness, sensitiveity to cold

Clematis erecta......................skin irritations, neuralgic pains

Clematis vitalba, flos...........physical and emotional weakness

Ferrum phosphoricum...................nervous sensitivity, fevers

Histaminum hydrochloricum.............inflammation, sensitivity

Hypericum perforatum..shock, puncture wounds, joint injuries

Ignatia amara..................................fear, stress, impatience

Impatiens glandulifera, flos..susceptibility to illness, premature

aging

Ornithogalum umbellatum, flos...illness from shock and trauma

Passiflora incarnata....................................worry, exhaustion

Phosphorus...................................oversensitivity, fearfulness

Prunus cerasifera, flos.................tension, fear of losing control

Rhus tox...................................strains, sprains, inflammation

Sulphur...........................................skin irritations, irritability

Symphytum officinale.........pain, strains, sprains, inflammation

Trifolium pratense...................promotes calm steady presence

Veratrum album................................minor anxiety and shock

Reference image: Frist Aid Mind and Body.jpg

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First Aid Mind and Body - FDA Drug Approval Details