Ohm Skin Healing Gel (Calendula Officinalis, Stellaria Media, Calcarea Sulphurica, Chamomilla, Echinacea Angustfolia, Silicea, Symphytum Officinale, Thiosinamium, Hamamelis Virginiana.) Gel [ -

OHM SKIN HEALING GEL (CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.) GEL [
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NDC	66096-139-10
Set ID	f97dffe6-cddc-4577-afcc-deadb7abd0c6
Category	HUMAN OTC DRUG LABEL
Packager	OHM PHARMA INC.
Generic Name
Product Class
Product Number
Application Number

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - OHM PHARMA INC. (030572478)

Registrant - OHM PHARMA INC. (030572478)

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

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Medic