Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 5c741edc-f3ce-4e43-bb3e-fb7316621406
Route
ORAL
Published
Effective Date 2023-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-07-19 Until 2028-08-10

Description

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

Purpose

For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.


Medication Information

Purpose

For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Description

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

Purpose:

For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.**

**These statements are based upon 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 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.

Indications:

For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.**

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

Active Ingredients:

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

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

DESBIO

NDC 43742-2088-1

HOMEOPATHIC

GUM

THERAPY

1 FL OZ (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.**

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

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.

Indications: (INDICATIONS:)

For temporary relief of symptoms related to inflamed and bleeding gums and minor pain.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-2088-1

HOMEOPATHIC

GUM

THERAPY

1 FL OZ (30 ml)

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

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


Advanced Ingredient Data


Raw Label Data

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