FDA.reportPublic FDA data

Hemorrhoid Gel

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:19:30

Label at a glance#

ProductHemorrhoid Gel
Active ingredientACHILLEA MILLEFOLIUM WHOLE, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, RUSCUS ACULEATUS WHOLE, ALOE, PAEONIA OFFICINALIS ROOT, STRYCHNOS IGNATII SEED, NITRIC ACID, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PODOPHYLLUM, PULSATILLA VULGARIS WHOLE, KRAMERIA LAPPACEA ROOT, HORSE CHESTNUT, CHELIDONIUM MAJUS WHOLE, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

OTC - PURPOSE SECTION

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Lubricate applicator with a small amount of gel before use. Apply to area 5 to 6 times daily, especially after a bowel movement.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • FOR TOPICAL USE ONLY.
  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Carbomer 980, Ethanol Alcohol, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide, USP Glycerin

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:43406-0709-5

Hemorrhoid Gel

HOMEOPATHIC

 2 oz (56.7g)

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0709-5Hemorrhoid Gel56.7 g in 1 TUBE, WITH APPLICATORGEL56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0709HEMORRHOID GEL (ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, RUSCUS ACULEATUS, ALOE SOCOTRINA, PAEONIA OFFICINALIS, IGNATIA AMARA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PEITATUM, PULSATILLA, RATANHIA, CHELIDONIUM MAJUS, SULPHUR) GEL [NATURAL CREATIONS, INC]1Current NDC, Legacy NDC, 1 package rows20230111_d2016513-9b47-490d-9396-766db4cafecd.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-070943406-0709-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
RUSCUS ACULEATUS WHOLE5KEZ82GMGUACTIB
ALOEV5VD430YW9ACTIB
PAEONIA OFFICINALIS ROOT8R564U2E1PACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
NITRIC ACID411VRN1TV4ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
PODOPHYLLUM2S713A4VP3ACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
KRAMERIA LAPPACEA ROOTP29ZH1A35ZACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
SULFUR70FD1KFU70ACTIB
CARBOMER 9804Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT

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
Hemorrhoid GelACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, RUSCUS ACULEATUS, ALOE SOCOTRINA, PAEONIA OFFICINALIS, IGNATIA AMARA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PEITATUM, PULSATILLA, RATANHIA, CHELIDONIUM MAJUS, SULPHURNatural Creations, Incd2016513-9b47-490d-9396-766db4cafecd2018-12-21WarningsExact identifier
ndc (package): 43406-0709-5
ndc (product): 43406-0709
ndc11 (package): 43406070905
spl id: a515d3ae-7a24-45b9-9bcf-a3ec565cd89c
spl set id: d2016513-9b47-490d-9396-766db4cafecd

Reported adverse events (FAERS/openFDA)#

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