Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 0cf8a815-808d-4018-baf9-2b4545fc7ea8
Route
ORAL
Published
Effective Date 2019-08-20
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]) Agave Americana Leaf (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 2019-08-20 Until 2027-04-25

Description

Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica Montana 3X, 6X, 12X, 30X, Agave Americana 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.


Medication Information

Description

Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica Montana 3X, 6X, 12X, 30X, Agave Americana 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.

Warnings:

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

If pregnant or breast-feeding, seek advice of 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:

Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica Montana 3X, 6X, 12X, 30X, Agave Americana 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 43742-1509-1

HOMEOPATHIC

GUM

THERAPY

1 FL OZ (30 ml)

Homeopathic Indications:

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

**These statements are based upon traditional 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 physician or Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

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

If pregnant or breast-feeding, seek advice of 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:)

Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica Montana 3X, 6X, 12X, 30X, Agave Americana 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 43742-1509-1

HOMEOPATHIC

GUM

THERAPY

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

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

**These statements are based upon traditional 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 physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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