Ohm Skin Healing Gel

Ohm Skin Healing Gel
SPL v4
SPL
SPL Set ID f97dffe6-cddc-4577-afcc-deadb7abd0c6
Route
TOPICAL
Published
Effective Date 2019-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X]) Stellaria Media (3 [hp_X]) Calcium Cation (6 [hp_X]) Matricaria Recutita Echinacea Angustifolia Silicon Dioxide Comfrey Root Allylthiourea Hamamelis Virginiana Root Bark/stem Bark
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Alcohol Glycerin Aloe Vera Leaf Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-11-16

Description

ACTIVE INGREDIENTS (HPUS*): Calendula Officinalis 1X 3.5%, Stellaria Media 1X 1.25%, Calcarea Sulphurica 3X 1%, Chamomilla 1X 1%, Echinacea Angustfolia 1X 1%, Silicea 3X 1%, Symphytum Officinale 6X 1%, Thiosinamium 3X 1%, Hamamelis Virginiana 1X 0.25%. ​*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: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKEN SKIN. IF PREGNANT OR BREAST - FEEDING, ask a health care professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Indications and Usage

USES: Temporarily relieves scrapes, burns and skin irritation.**

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

Dosage and Administration

DIRECTIONS: Apply a small amount to affected area 3 times a day or as directed by a health care professional.

Description

ACTIVE INGREDIENTS (HPUS*): Calendula Officinalis 1X 3.5%, Stellaria Media 1X 1.25%, Calcarea Sulphurica 3X 1%, Chamomilla 1X 1%, Echinacea Angustfolia 1X 1%, Silicea 3X 1%, Symphytum Officinale 6X 1%, Thiosinamium 3X 1%, Hamamelis Virginiana 1X 0.25%. ​*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 REACH OF CHILDREN
Section 51727-6

INACTIVE INGREDIENTS: Carbomer 980, Ethyl Alcohol, Glycerin, Organic Aloe Vera, Purified Water, Sodium Hydroxide Solution 18%.

Section 51945-4

NDC: 66096-139-10

OHM

SKIN HEALING GEL

Burns *Skin Irritation

Natural - Safe - Effective

TOPICAL HOMEOPATHIC

Net Wt: 3.40oz (96.5g)

Made In Usa

Section 53413-1

MFG. By: OHM PHARMA, INC. / Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1

Burns and Skin Irritation

Section 55106-9

ACTIVE INGREDIENTS (HPUS*): Calendula Officinalis 1X 3.5%, Stellaria Media 1X 1.25%, Calcarea Sulphurica 3X 1%, Chamomilla 1X 1%, Echinacea Angustfolia 1X 1%, Silicea 3X 1%, Symphytum Officinale 6X 1%, Thiosinamium 3X 1%, Hamamelis Virginiana 1X 0.25%.

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

Section 60561-8

OTHER INFORMATION: TAMPER EVIDENT - Do not use if seal is broken or missing. Store at room temperature. Petroleum Free, Paraben Free, Propylene Glycol Free.


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves scrapes, burns and skin irritation.**

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

Dosage and Administration (34068-7)

DIRECTIONS: Apply a small amount to affected area 3 times a day or as directed by a health care professional.

Warnings and Precautions (34071-1)

WARNINGS: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKEN SKIN. IF PREGNANT OR BREAST - FEEDING, ask a health care professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

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

INACTIVE INGREDIENTS: Carbomer 980, Ethyl Alcohol, Glycerin, Organic Aloe Vera, Purified Water, Sodium Hydroxide Solution 18%.

Section 51945-4 (51945-4)

NDC: 66096-139-10

OHM

SKIN HEALING GEL

Burns *Skin Irritation

Natural - Safe - Effective

TOPICAL HOMEOPATHIC

Net Wt: 3.40oz (96.5g)

Made In Usa

Section 53413-1 (53413-1)

MFG. By: OHM PHARMA, INC. / Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1 (55105-1)

Burns and Skin Irritation

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*): Calendula Officinalis 1X 3.5%, Stellaria Media 1X 1.25%, Calcarea Sulphurica 3X 1%, Chamomilla 1X 1%, Echinacea Angustfolia 1X 1%, Silicea 3X 1%, Symphytum Officinale 6X 1%, Thiosinamium 3X 1%, Hamamelis Virginiana 1X 0.25%.

​*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)

OTHER INFORMATION: TAMPER EVIDENT - Do not use if seal is broken or missing. Store at room temperature. Petroleum Free, Paraben Free, Propylene Glycol Free.


Advanced Ingredient Data


Raw Label Data

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