Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID ceb5203b-b4c8-4c7b-8e18-ccbff5034fc1
Route
ORAL
Published
Effective Date 2024-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (12 [hp_X]) Arnica Montana (3 [hp_X]) Bismuth Cation (6 [hp_X]) Borate Ion (8 [hp_X]) Fluoride Ion (1 [hp_X]) Calendula Officinalis Flowering Top Helianthemum Canadense Calcium Sulfide Phosphate Ion Wood Creosote Mercury Myrrh Chloride Ion Sepia Officinalis Juice
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-08-28

Description

Aconitum Napellus 12X, Arnica Montana 3X, 6X, 12X, 30X, Bismuthum Subnitricum 12X, Borax 6X, Calcarea Fluorica 8X, Calendula Officinalis 1X, 6X, 12X, 30X, Cistus Canadensis 12X, Hepar Sulphuris Calcareum 12X, 18X, 30X, Kali Phosphoricum 3X, Kreosotum 6X, Mercurius Vivus 12X, 18X, 30X, Myrrha 6X, Natrum Muriaticum 3X, Sepia 12X.

Purpose

Aconitum Napellus – Pain in Gums, Arnica Montana – Bleeding Gums, Bismuthum Subnitricum – Gum Support, Borax – Gum Support, Calcarea Fluorica – Pain in Gums, Calendula Officinalis – Bleeding Gums, Cistus Canadensis – Gum Support, Hepar Sulphuris Calcareum – Pain in Gums, Kali Phosphoricum – Bleeding Gums, Kreosotum – Pain in Gums, Mercurius Vivus – Bleeding Gums, Myrrha – Gum Support, Natrum Muriaticum – Gum Support, Sepia – Bleeding Gums


Medication Information

Purpose

Aconitum Napellus – Pain in Gums, Arnica Montana – Bleeding Gums, Bismuthum Subnitricum – Gum Support, Borax – Gum Support, Calcarea Fluorica – Pain in Gums, Calendula Officinalis – Bleeding Gums, Cistus Canadensis – Gum Support, Hepar Sulphuris Calcareum – Pain in Gums, Kali Phosphoricum – Bleeding Gums, Kreosotum – Pain in Gums, Mercurius Vivus – Bleeding Gums, Myrrha – Gum Support, Natrum Muriaticum – Gum Support, Sepia – Bleeding Gums

Description

Aconitum Napellus 12X, Arnica Montana 3X, 6X, 12X, 30X, Bismuthum Subnitricum 12X, Borax 6X, Calcarea Fluorica 8X, Calendula Officinalis 1X, 6X, 12X, 30X, Cistus Canadensis 12X, Hepar Sulphuris Calcareum 12X, 18X, 30X, Kali Phosphoricum 3X, Kreosotum 6X, Mercurius Vivus 12X, 18X, 30X, Myrrha 6X, Natrum Muriaticum 3X, Sepia 12X.

Uses:

• For the temporary relief of symptoms including:

• gum support • bleeding gums • pain in gums

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

Purpose:

Aconitum Napellus – Pain in Gums, Arnica Montana – Bleeding Gums, Bismuthum Subnitricum – Gum Support, Borax – Gum Support, Calcarea Fluorica – Pain in Gums, Calendula Officinalis – Bleeding Gums, Cistus Canadensis – Gum Support, Hepar Sulphuris Calcareum – Pain in Gums, Kali Phosphoricum – Bleeding Gums, Kreosotum – Pain in Gums, Mercurius Vivus – Bleeding Gums, Myrrha – Gum Support, Natrum Muriaticum – Gum Support, Sepia – Bleeding Gums

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:

Aconitum Napellus 12X, Arnica Montana 3X, 6X, 12X, 30X, Bismuthum Subnitricum 12X, Borax 6X, Calcarea Fluorica 8X, Calendula Officinalis 1X, 6X, 12X, 30X, Cistus Canadensis 12X, Hepar Sulphuris Calcareum 12X, 18X, 30X, Kali Phosphoricum 3X, Kreosotum 6X, Mercurius Vivus 12X, 18X, 30X, Myrrha 6X, Natrum Muriaticum 3X, Sepia 12X.

Inactive Ingredients:

Demineralized water, 25% ethanol

Package Label Display:

DesBio 

Gum Therapy

Homeopathic

NDC 43742-2195-1

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:

• gum support • bleeding gums • pain in gums

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

Purpose: (PURPOSE:)

Aconitum Napellus – Pain in Gums, Arnica Montana – Bleeding Gums, Bismuthum Subnitricum – Gum Support, Borax – Gum Support, Calcarea Fluorica – Pain in Gums, Calendula Officinalis – Bleeding Gums, Cistus Canadensis – Gum Support, Hepar Sulphuris Calcareum – Pain in Gums, Kali Phosphoricum – Bleeding Gums, Kreosotum – Pain in Gums, Mercurius Vivus – Bleeding Gums, Myrrha – Gum Support, Natrum Muriaticum – Gum Support, Sepia – Bleeding Gums

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:)

Aconitum Napellus 12X, Arnica Montana 3X, 6X, 12X, 30X, Bismuthum Subnitricum 12X, Borax 6X, Calcarea Fluorica 8X, Calendula Officinalis 1X, 6X, 12X, 30X, Cistus Canadensis 12X, Hepar Sulphuris Calcareum 12X, 18X, 30X, Kali Phosphoricum 3X, Kreosotum 6X, Mercurius Vivus 12X, 18X, 30X, Myrrha 6X, Natrum Muriaticum 3X, Sepia 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DesBio 

Gum Therapy

Homeopathic

NDC 43742-2195-1

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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