FDA.reportPublic FDA data

Acne Relief Gel

Manufacturer
OHM PHARMA INC.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:21

Label at a glance#

ProductAcne Relief Gel
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA CHAMOMILLA, BERBERIS AQUIFOLIUM ROOT BARK, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, SULFUR
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Drug Facts:

​ACTIVE INGREDIENTS (HPUS*): Each 100g contains: Calendula Officinalis 1X 5g, Chamomilla 1X 3g, Berberis Aquafolium 2X 3g, Hamamelis 2X 1g, Hepar Sulph. Calc. 6X 1g, Sulphur 6X 1g.

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

* ​Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves pimples, blemishes, redness and swelling due to simple acne. Promotes natural skin healing.**

WARNINGS SECTION

WARNINGS: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKE SKIN. KEEP OUT OF REACH OF CHILDREN. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a healthcare professional. IF SWALLOWED, 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, Ethythexyglycerin, Glycerin, Organic Aloe Vera Powder, Phenoxythanol, Purified Water, Sodium Hydroxide.

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS?

Mfg. By: OHM PHARMA, INC.

Mineral Wells, TX 76067

www.ohmpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 66096-747-03

ACNE RELIEF GEL

Natural - Safe - Effective

No Side Effects

Net Wt: 1.75 oz (50 g)

ohm

PHARMA

​Your Partner in Homeopathy

Acne Relief Gel 50g Bottle LabelAcne Relief Gel 50g Bottle Label

OTC - PURPOSE SECTION

Temporay relieves pimples, blemishes, redness and swelling due to simple acne. Promotes natural skin healing. **

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-747-03Acne Relief Gel50 g in 1 TUBEGEL503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-747ACNE RELIEF GEL (CALENDULA OFFICINALIS, CHAMOMILLA, BERBERIS AQUAFOLIUM, HAMAMELIS, HEPAR SULPH. CALC. , SULPHUR) GEL [OHM PHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20211230_43f669ef-2ebd-46c8-adb6-84bea30a7c0b.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-74766096-747-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
BERBERIS AQUIFOLIUM ROOT BARKVZJ9F3C3SBACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
SULFUR70FD1KFU70ACTIB

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
Acne Relief GelCALENDULA OFFICINALIS, CHAMOMILLA, BERBERIS AQUAFOLIUM, HAMAMELIS, HEPAR SULPH. CALC. , SULPHUROHM PHARMA INC.43f669ef-2ebd-46c8-adb6-84bea30a7c0b2021-12-29WarningsExact identifier
ndc (package): 66096-747-03
ndc (product): 66096-747
ndc11 (package): 66096074703
spl id: d44ae412-0004-a536-e053-2a95a90af73f
spl set id: 43f669ef-2ebd-46c8-adb6-84bea30a7c0b

Reported adverse events (FAERS/openFDA)#

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