SEVENE USA - Comfort Down There - Hemorrhoids

Manufacturer
SEVENE USA
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:00:57

Label at a glance#

ProductComfort Down There Hemorrhoids
Active ingredientCAPSICUM ANNUUM WHOLE, STRYCHNOS NUX-VOMICA SEED, ALOE FEROX WHOLE, AESCULUS HIPPOCASTANUM WHOLE, BERBERIS VULGARIS ROOT BARK, PULSATILLA VULGARIS WHOLE, SILYBUM MARIANUM SEED
Label structure11 sections

Storage and handling

Store at 59-77°F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Aesculus Hippocastanum 5C - Aloe 5C - Berberis Vulgaris 3C – Capsicum Annuum 5C - Carduus Marianus 3C - Nux Vomica 5C - Pulsatilla 9C.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to Relieve Symptoms of Hemorrhoids:

- Soreness, Tenderness, Burning, Itching

- Constipation

- Pain after Bowel Movements

DOSAGE & ADMINISTRATION SECTION

Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INDICATIONS & USAGE SECTION

AESCULUS HIPPOCASTANUM

Hemorrhoids Pain - Venous Congestion .*

ALOE

Hemorrhoids - Urgent Diarrhea .*

BERBERIS VULGARIS

Radiating, Painful, Frequent urination - Skin rash with round, red patches and

thin flakes .*

CAPSICUM ANNUUM

Stuffy, Runny Nose with Sneezing and Post Nasal Drip - Sore Throat with Burning Pain .*

CARDUUS MARIANUS

Hemorrhoids .*

NUX VOMICA

Indigestion, Heartburn, Drowsiness after Meals, Nausea from Overindulgence/Overeating .*

PULSATILLA

Ocular or Nasal Yellow Discharge Associated with Cold .*

WARNINGS SECTION

Consult a physician for use in children under 6 years of age.

Contact a doctor if symptoms persist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Store at 59-77°F.

OTC - DO NOT USE SECTION

Do not use if seal is broken or missing.

INACTIVE INGREDIENT SECTION

Organic Alcohol 20%

Purified Water

QUESTIONS?

OTC - QUESTIONS SECTION

Distributed by Sevene USA

East Troy, WI 53120 USA

1-855 - OLLOMED

QUESTIONS? info@ollois.com

www.ollois.com

MADE IN FRANCE.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. No guarantee to be effective. A homeopathic dilution may not to be susceptible to scientific measurement. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

étiquette 10étiquette 10étuis 10étuis 10

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-700976472-7009-1, 76472-7009-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
Comfort Down There HemorrhoidsAESCULUS HIPPOCASTANUM 5C, ALOE 5C, BERBERIS VULGARIS 3C, CAPSICUM ANNUUM 5C, CARDUUS MARIANUS 3C, NUX VOMICA 5C, PULSATILLA 9CSEVENE USA55001764-8bc9-cbac-e063-6394a90a455c2026-08-18WarningsExact identifier
ndc (package): 76472-7009-1
ndc (package): 76472-7009-2
ndc (product): 76472-7009
ndc11 (package): 76472700901
ndc11 (package): 76472700902
spl id: 594f5100-8657-45a9-e063-6394a90a3ce5
spl set id: 55001764-8bc9-cbac-e063-6394a90a455c

Reported adverse events (FAERS/openFDA)#

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