Ohm Mouthwash

Ohm Mouthwash
SPL v4
SPL
SPL Set ID 4fa493ff-9ea2-4e17-9e16-994c11207440
Route
ORAL
Published
Effective Date 2019-09-10
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_X]) Borate Ion (1 [hp_X]) Calendula Officinalis Flowering Top (6 [hp_X]) Hypericum Perforatum Myrrh Plantago Major Krameria Lappacea Root Sage Comfrey Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-09-15

Description

ACTIVE INGREDIENTS (HPUS): Equal amounts of: Arnica Montana 3X, Borax 3X, Calendula Officinalis 1X, Hypericum Perforatum 3X, Myrrha 3X, Plantago Major 1X, Ratanhia 3X, Salvia Officinalis 1X, Symphytum Officinale 6X. * ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.


Medication Information

Warnings and Precautions

WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than a week, discontinue use and contact a doctor.

Indications and Usage

USES: Temporarily relieves sensitive, bleeding gums and gingivitis.**

​**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

Dosage and Administration

DIRECTIONS: Shake 10 times before use. Adults & children over 12 years old: add 10-15 drops to half a tablespoon of water and rinse the gums for 1 minute. Use 2 times a day, or as directed by a health care professional. Children under 12: use half the adult dose.

Description

ACTIVE INGREDIENTS (HPUS): Equal amounts of: Arnica Montana 3X, Borax 3X, Calendula Officinalis 1X, Hypericum Perforatum 3X, Myrrha 3X, Plantago Major 1X, Ratanhia 3X, Salvia Officinalis 1X, Symphytum Officinale 6X. * ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 50565-1
  • ​KEEP OUT OF THE REACH OF CHILDREN.
Section 51727-6

INACTIVE INGREDIENTS: Ethanol Alcohol 70% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water.

Section 51945-4

HOMEOPATHIC MEDICINE

NDC: 66096-159-05

MOUTHWASH

Natural - Safe - Effective

No Side Effects

2 fl oz (59mL) / 70% Alcohol

PRODUCT OF USA

Section 53413-1

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1

Temporarily relieves sensitive, bleeding gums and gingivitis.

Section 55106-9

ACTIVE INGREDIENTS (HPUS): Equal amounts of: Arnica Montana 3X, Borax 3X, Calendula Officinalis 1X, Hypericum Perforatum 3X, Myrrha 3X, Plantago Major 1X, Ratanhia 3X, Salvia Officinalis 1X, Symphytum Officinale 6X.

* ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 60561-8

Do not use if cap seal is broken.


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves sensitive, bleeding gums and gingivitis.**

​**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

Dosage and Administration (34068-7)

DIRECTIONS: Shake 10 times before use. Adults & children over 12 years old: add 10-15 drops to half a tablespoon of water and rinse the gums for 1 minute. Use 2 times a day, or as directed by a health care professional. Children under 12: use half the adult dose.

Warnings and Precautions (34071-1)

WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than a week, discontinue use and contact a doctor.

Section 50565-1 (50565-1)
  • ​KEEP OUT OF THE REACH OF CHILDREN.
Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethanol Alcohol 70% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water.

Section 51945-4 (51945-4)

HOMEOPATHIC MEDICINE

NDC: 66096-159-05

MOUTHWASH

Natural - Safe - Effective

No Side Effects

2 fl oz (59mL) / 70% Alcohol

PRODUCT OF USA

Section 53413-1 (53413-1)

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1 (55105-1)

Temporarily relieves sensitive, bleeding gums and gingivitis.

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS): Equal amounts of: Arnica Montana 3X, Borax 3X, Calendula Officinalis 1X, Hypericum Perforatum 3X, Myrrha 3X, Plantago Major 1X, Ratanhia 3X, Salvia Officinalis 1X, Symphytum Officinale 6X.

* ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 60561-8 (60561-8)

Do not use if cap seal is broken.


Advanced Ingredient Data


Raw Label Data

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