Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 81ffb30f-5255-4e16-ba9d-b0de909aa557
Route
ORAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Borate Ion (6 [hp_X]) Bryonia Alba Root (8 [hp_X]) Echinacea Purpurea (12 [hp_X]) Juglans Cinerea Branch Bark/root Bark (16 [hp_X]) Potassium Cation (12 [hp_C]) Magnesium Cation Hydrochloric Acid Sus Scrofa Intervertebral Disc Sus Scrofa Oral Mucosa Antimony Trisulfide Arsenic Cation (3+) Bismuth Cation Matricaria Chamomilla Cinchona Officinalis Bark Nutmeg Sambucus Nigra Flowering Top Sepia Officinalis Juice Mercurius Solubilis Calcium Cation Strychnos Ignatii Seed Oxygen Candida Albicans Staphylococcus Aureus Streptococcus Mutans
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2020-02-19 Until 2028-09-19

Description

Borax 6X, Bryonia (Alba) 6X, Echinacea Purpurea 6X, Juglans Cinerea 6X, Kali Muriaticum 6X, Magnesia Muriatica 6X, Muriaticum Acidum 6X, Discus Intervertebralis Suis 8X, 12X, 18X, 24X, 30X, Oral Mucosa (Suis) 8X, 12X, 18X, 24X, 30X, Antimonium Crudum 12X, Arsenicum Album 12X, Bismuthum Subnitricum 12X, Chamomilla 12X, Cinchona Officinalis 12X, Nux Moschata 12X, Sambucus Nigra 12X, Sepia 12X, Mercurius Solubilis 12X, 18X, 24X, 30X, Calcarea Phosphorica 12X, 18X, 30X, Ignatia Amara 12X, 30X, Oxygenium 16X, Candida Albicans 16X, 18X, 24X, 30X, Staphylococcus Aureus 12C, 18C, 24C, 30C, Streptococcus Mutans 12C, 18C, 24C, 30C.


Medication Information

Description

Borax 6X, Bryonia (Alba) 6X, Echinacea Purpurea 6X, Juglans Cinerea 6X, Kali Muriaticum 6X, Magnesia Muriatica 6X, Muriaticum Acidum 6X, Discus Intervertebralis Suis 8X, 12X, 18X, 24X, 30X, Oral Mucosa (Suis) 8X, 12X, 18X, 24X, 30X, Antimonium Crudum 12X, Arsenicum Album 12X, Bismuthum Subnitricum 12X, Chamomilla 12X, Cinchona Officinalis 12X, Nux Moschata 12X, Sambucus Nigra 12X, Sepia 12X, Mercurius Solubilis 12X, 18X, 24X, 30X, Calcarea Phosphorica 12X, 18X, 30X, Ignatia Amara 12X, 30X, Oxygenium 16X, Candida Albicans 16X, 18X, 24X, 30X, Staphylococcus Aureus 12C, 18C, 24C, 30C, Streptococcus Mutans 12C, 18C, 24C, 30C.

Warnings:

Keep out of reach of children. In case of overdose, Contact a physician or 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.

Questions:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

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:

Borax 6X, Bryonia (Alba) 6X, Echinacea Purpurea 6X, Juglans Cinerea 6X, Kali Muriaticum 6X, Magnesia Muriatica 6X, Muriaticum Acidum 6X, Discus Intervertebralis Suis 8X, 12X, 18X, 24X, 30X, Oral Mucosa (Suis) 8X, 12X, 18X, 24X, 30X, Antimonium Crudum 12X, Arsenicum Album 12X, Bismuthum Subnitricum 12X, Chamomilla 12X, Cinchona Officinalis 12X, Nux Moschata 12X, Sambucus Nigra 12X, Sepia 12X, Mercurius Solubilis 12X, 18X, 24X, 30X, Calcarea Phosphorica 12X, 18X, 30X, Ignatia Amara 12X, 30X, Oxygenium 16X, Candida Albicans 16X, 18X, 24X, 30X, Staphylococcus Aureus 12C, 18C, 24C, 30C, Streptococcus Mutans 12C, 18C, 24C, 30C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

DESBIO

NDC 43742-1592-1

HOMEOPATHIC

ORAL

HEALTH

1 FL OZ (30 ml)

Homeopathic Indications:

For the temporary relief of symptoms related to oral health, such as cavitation, delayed dentition, dry mouth, painful eating, eruptions on tongue and inner cheeks and tooth sensitivity.**

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

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.


Structured Label Content

Warnings: (WARNINGS:)

Keep out of reach of children. In case of overdose, Contact a physician or 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.

Questions: (QUESTIONS:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

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:)

Borax 6X, Bryonia (Alba) 6X, Echinacea Purpurea 6X, Juglans Cinerea 6X, Kali Muriaticum 6X, Magnesia Muriatica 6X, Muriaticum Acidum 6X, Discus Intervertebralis Suis 8X, 12X, 18X, 24X, 30X, Oral Mucosa (Suis) 8X, 12X, 18X, 24X, 30X, Antimonium Crudum 12X, Arsenicum Album 12X, Bismuthum Subnitricum 12X, Chamomilla 12X, Cinchona Officinalis 12X, Nux Moschata 12X, Sambucus Nigra 12X, Sepia 12X, Mercurius Solubilis 12X, 18X, 24X, 30X, Calcarea Phosphorica 12X, 18X, 30X, Ignatia Amara 12X, 30X, Oxygenium 16X, Candida Albicans 16X, 18X, 24X, 30X, Staphylococcus Aureus 12C, 18C, 24C, 30C, Streptococcus Mutans 12C, 18C, 24C, 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-1592-1

HOMEOPATHIC

ORAL

HEALTH

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For the temporary relief of symptoms related to oral health, such as cavitation, delayed dentition, dry mouth, painful eating, eruptions on tongue and inner cheeks and tooth sensitivity.**

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

Keep Out of Reach of Children: (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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