OHM SKIN HEALING GEL- calendula officinalis, stellaria media, calcarea sulphurica, chamomilla, echinacea angustfolia, silicea, symphytum officinale, thiosinamium, hamamelis virginiana. gel

OHM Skin Healing Gel by

Drug Labeling and Warnings

OHM Skin Healing Gel by is a Homeopathic medication manufactured, distributed, or labeled by OHM PHARMA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

INDICATIONS & 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.

WARNINGS

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.

• ​KEEP OUT OF REACH OF CHILDREN​

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

Burns and Skin Irritation

INGREDIENTS AND APPEARANCE

OHM SKIN HEALING GEL 
calendula officinalis, stellaria media, calcarea sulphurica, chamomilla, echinacea angustfolia, silicea, symphytum officinale, thiosinamium, hamamelis virginiana. gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66096-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 96.5 g
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	1 [hp_X]  in 96.5 g
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE ANHYDROUS	3 [hp_X]  in 96.5 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	1 [hp_X]  in 96.5 g
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X]  in 96.5 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	3 [hp_X]  in 96.5 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 96.5 g
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7)	ALLYLTHIOUREA	3 [hp_X]  in 96.5 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]  in 96.5 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66096-139-10	96.5 g in 1 TUBE; Type 0: Not a Combination Product	11/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/16/2016

Labeler - OHM PHARMA INC. (030572478)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(66096-139)