drug facts:

drug facts:
SPL v4
SPL
SPL Set ID 3a117358-3c51-4870-9932-701ffe90e3f8
Route
oral
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetic acid (3 [hp_X]) calendula officinalis flowering top (6 [hp_X]) ginger (8 [hp_X]) bryonia alba root (12 [hp_X]) coffea arabica seed, roasted ledum palustre twig phosphorus plantago major spigelia anthelmia arnica montana matricaria chamomilla calcium sulfide hypericum perforatum aconitum napellus antimony trisulfide daphne mezereum bark sepia officinalis juice delphinium staphisagria seed magnesium cation
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2019-08-21

Purpose

Aceticum Acidum – Dental Pain, Aconitum Napellus – Sensitive Teeth, Antimonium Crudum - Salivation, Arnica Montana – Cramping in the Jaw, Bryonia (Alba) – Sensitivity to Temperature, Calendula Officinalis – Sensitivity to Brushing, Chamomilla – Sensitivity to Brushing, Coffea Tosta – Dental Pain, Hepar Sulphuris Calcareum – Dental Pain, Hypericum Perforatum – Sensitive Teeth, Ledum Palustre - Salivation, Magnesia Phosphorica – Cramping in the Jaw, Mezereum – Sensitivity to Temperature, Phosphorus – Sensitivity to Brushing, Plantago Major - Salivation, Sepia – Dental Pain, Spigelia Anthelmia – Sensitive Teeth, Staphysagria – Generalized Dental Discomfort, Zingiber Officinale – Sensitive Teeth

Description

Aceticum Acidum 3X, Aconitum Napellus 12X, Antimonium Crudum 12X, Arnica Montana 6X, 12X, 18X, 30X, Bryonia (Alba) 6X, Calendula Officinalis 3X, Chamomilla 6X, 12X, 18X, 30X, Coffea Tosta 6X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 8X, 12X, 18X, 30X, Ledum Palustre 6X, Magnesia Phosphorica 12X, 30X, Mezereum 12X, Phosphorus 6X, Plantago Major 6X, Sepia 12X, Spigelia Anthelmia 6X, Staphysagria 12X, 18X, 24X, 30X, Zingiber Officinale 3X.


Medication Information

Purpose

Aceticum Acidum – Dental Pain, Aconitum Napellus – Sensitive Teeth, Antimonium Crudum - Salivation, Arnica Montana – Cramping in the Jaw, Bryonia (Alba) – Sensitivity to Temperature, Calendula Officinalis – Sensitivity to Brushing, Chamomilla – Sensitivity to Brushing, Coffea Tosta – Dental Pain, Hepar Sulphuris Calcareum – Dental Pain, Hypericum Perforatum – Sensitive Teeth, Ledum Palustre - Salivation, Magnesia Phosphorica – Cramping in the Jaw, Mezereum – Sensitivity to Temperature, Phosphorus – Sensitivity to Brushing, Plantago Major - Salivation, Sepia – Dental Pain, Spigelia Anthelmia – Sensitive Teeth, Staphysagria – Generalized Dental Discomfort, Zingiber Officinale – Sensitive Teeth

Description

Aceticum Acidum 3X, Aconitum Napellus 12X, Antimonium Crudum 12X, Arnica Montana 6X, 12X, 18X, 30X, Bryonia (Alba) 6X, Calendula Officinalis 3X, Chamomilla 6X, 12X, 18X, 30X, Coffea Tosta 6X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 8X, 12X, 18X, 30X, Ledum Palustre 6X, Magnesia Phosphorica 12X, 30X, Mezereum 12X, Phosphorus 6X, Plantago Major 6X, Sepia 12X, Spigelia Anthelmia 6X, Staphysagria 12X, 18X, 24X, 30X, Zingiber Officinale 3X.

Uses:

• For the temporary relief of symptoms including:

• sensitivity to temperature • dental pain • sensitive teeth • cramping in jaw

• salivation • generalized dental discomfort • sensitivity to brushing

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Purpose:

Aceticum Acidum – Dental Pain, Aconitum Napellus – Sensitive Teeth, Antimonium Crudum - Salivation, Arnica Montana – Cramping in the Jaw, Bryonia (Alba) – Sensitivity to Temperature, Calendula Officinalis – Sensitivity to Brushing, Chamomilla – Sensitivity to Brushing, Coffea Tosta – Dental Pain, Hepar Sulphuris Calcareum – Dental Pain, Hypericum Perforatum – Sensitive Teeth, Ledum Palustre - Salivation, Magnesia Phosphorica – Cramping in the Jaw, Mezereum – Sensitivity to Temperature, Phosphorus – Sensitivity to Brushing, Plantago Major - Salivation, Sepia – Dental Pain, Spigelia Anthelmia – Sensitive Teeth, Staphysagria – Generalized Dental Discomfort, Zingiber Officinale – Sensitive Teeth

Warnings:

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

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

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Questions:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

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.

Active Ingredients:

Aceticum Acidum 3X, Aconitum Napellus 12X, Antimonium Crudum 12X, Arnica Montana 6X, 12X, 18X, 30X, Bryonia (Alba) 6X, Calendula Officinalis 3X, Chamomilla 6X, 12X, 18X, 30X, Coffea Tosta 6X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 8X, 12X, 18X, 30X, Ledum Palustre 6X, Magnesia Phosphorica 12X, 30X, Mezereum 12X, Phosphorus 6X, Plantago Major 6X, Sepia 12X, Spigelia Anthelmia 6X, Staphysagria 12X, 18X, 24X, 30X, Zingiber Officinale 3X.

Inactive Ingredients:

Demineralized water, 25% ethanol

Package Label Display:

DesBio

Dental Pain

Homeopathic

NDC 43742-1523-1

1 FL OZ (30 ml)

Keep Out of Reach of Children:

In case of overdose, contact a physician or Poison Control Center right away.


Structured Label Content

Uses: (USES:)

• For the temporary relief of symptoms including:

• sensitivity to temperature • dental pain • sensitive teeth • cramping in jaw

• salivation • generalized dental discomfort • sensitivity to brushing

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Purpose: (PURPOSE:)

Aceticum Acidum – Dental Pain, Aconitum Napellus – Sensitive Teeth, Antimonium Crudum - Salivation, Arnica Montana – Cramping in the Jaw, Bryonia (Alba) – Sensitivity to Temperature, Calendula Officinalis – Sensitivity to Brushing, Chamomilla – Sensitivity to Brushing, Coffea Tosta – Dental Pain, Hepar Sulphuris Calcareum – Dental Pain, Hypericum Perforatum – Sensitive Teeth, Ledum Palustre - Salivation, Magnesia Phosphorica – Cramping in the Jaw, Mezereum – Sensitivity to Temperature, Phosphorus – Sensitivity to Brushing, Plantago Major - Salivation, Sepia – Dental Pain, Spigelia Anthelmia – Sensitive Teeth, Staphysagria – Generalized Dental Discomfort, Zingiber Officinale – Sensitive Teeth

Warnings: (WARNINGS:)

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

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

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

Directions: (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.

Active Ingredients: (ACTIVE INGREDIENTS:)

Aceticum Acidum 3X, Aconitum Napellus 12X, Antimonium Crudum 12X, Arnica Montana 6X, 12X, 18X, 30X, Bryonia (Alba) 6X, Calendula Officinalis 3X, Chamomilla 6X, 12X, 18X, 30X, Coffea Tosta 6X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 8X, 12X, 18X, 30X, Ledum Palustre 6X, Magnesia Phosphorica 12X, 30X, Mezereum 12X, Phosphorus 6X, Plantago Major 6X, Sepia 12X, Spigelia Anthelmia 6X, Staphysagria 12X, 18X, 24X, 30X, Zingiber Officinale 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DesBio

Dental Pain

Homeopathic

NDC 43742-1523-1

1 FL OZ (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, contact a physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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