FDA.reportPublic FDA data

OHM Skin Healing Gel

Manufacturer
OHM PHARMA INC.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:31

Label at a glance#

ProductOHM Skin Healing Gel
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, STELLARIA MEDIA, CALCIUM SULFATE ANHYDROUS, MATRICARIA RECUTITA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, COMFREY ROOT, ALLYLTHIOUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • ​KEEP OUT OF REACH OF CHILDREN​

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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

3.40oz tube label3.40oz tube label

OTC - PURPOSE SECTION

Burns and Skin Irritation

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-139-10OHM Skin Healing Gel96.5 g in 1 TUBEGEL96.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-139OHM SKIN HEALING GEL (CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.) GEL [OHM PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20211230_f97dffe6-cddc-4577-afcc-deadb7abd0c6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-13966096-139-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
STELLARIA MEDIA2H03479QVRACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
COMFREY ROOTM9VVZ08EKQACTIB
ALLYLTHIOUREA706IDJ14B7ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OHM Skin Healing GelCALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.OHM PHARMA INC.f97dffe6-cddc-4577-afcc-deadb7abd0c62021-12-29WarningsExact identifier
ndc (package): 66096-139-10
ndc (product): 66096-139
ndc11 (package): 66096013910
spl id: d44bc6dd-32bc-59c7-e053-2995a90a7d11
spl set id: f97dffe6-cddc-4577-afcc-deadb7abd0c6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.