FDA.reportPublic FDA data

OHM Skin Growths 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 02:15:30

Label at a glance#

ProductOHM Skin Growths
Active ingredientTHUJA OCCIDENTALIS LEAFY TWIG, BAPTISIA TINCTORIA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, GOLDENSEAL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Each 100g contains: Thuja Occ. 1X 2g, Baptisia Tinctoria 1X 1g, Calendula Officinalis 1X 1g, Hydrastis Canadensis 5X 1g.

* ​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 scaly, rough skin with tendency to overgrowths, warts and fungal infections.**

​**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. AVOID CONTACT WITH EYES. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. If symptoms worsen or persist for more than a week, discontinue use and consult a doctor. In case of 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: Do not use if TAMPER EVIDENT seal is broken or missing. Store at room temperature.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Carbomer 980, Glycerin, Ethyl Alcohol, Cedar Oil, Geranium Oil, Lavender Oil, Lemon Oil, Lemongrass Oil, Purified Water, Sodium Hydroxide, Tea Tree Oil.

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS? Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC MEDICINE

NDC: 66096-699-20

SKIN GROWTHS GEL

Natural - Safe - Effective

No Side Effects

Net Wt: 2 oz (56.7 g)

Product of USA                                                                          

2oz bottle label2oz bottle label2oz bottle label2oz bottle label

OTC - PURPOSE SECTION

Relieves scaly, rough skin.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-699-20OHM Skin Growths56.7 g in 1 BOTTLE, PUMPGEL56.74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-699OHM SKIN GROWTHS (THUJA OCC., BAPTISIA TINCTORIA, CALENDULA OFFICINALIS, HYDRASTIS CANADENSIS.) GEL [OHM PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20211230_eca586e5-7f7c-48c5-b2e4-0c3074610302.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-69966096-699-20

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 9804Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
CEDAR LEAF OILBJ169U4NLGIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
LAVENDER OILZBP1YXW0H8IACT
LEMON OILI9GRO824LLIACT
WEST INDIAN LEMONGRASS OIL5BIA40E9EDIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
TEA TREE OILVIF565UC2GIACT
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
GOLDENSEALZW3Z11D0JVACTIB

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 GrowthsTHUJA OCC., BAPTISIA TINCTORIA, CALENDULA OFFICINALIS, HYDRASTIS CANADENSIS.OHM PHARMA INC.eca586e5-7f7c-48c5-b2e4-0c30746103022021-12-29WarningsExact identifier
ndc (package): 66096-699-20
ndc (product): 66096-699
ndc11 (package): 66096069920
spl id: d44bbea7-073b-14e0-e053-2995a90abb41
spl set id: eca586e5-7f7c-48c5-b2e4-0c3074610302

Reported adverse events (FAERS/openFDA)#

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