FDA.reportPublic FDA data

SEVENE USA - Bladder Calm - Urinary Infection

Manufacturer
SEVENE USA
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:00:50

Label at a glance#

ProductBladder Calm Urinary Infection
Active ingredientFORMICA RUFA, URTICA URENS, EQUISETUM HYEMALE, ARCTOSTAPHYLOS UVA-URSI LEAF
Label structure11 sections

Storage and handling

Store at 59-77°F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT HPUS

OTC - ACTIVE INGREDIENT SECTION

Equisetum Hyemale 3C - Formica Rufa 5C - Urtica Urens 3C - Uva Ursi 3C.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of urinary infection:

- Frequent Urging, Burning

- Uncomfortable Urination

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

EQUISETUM HYEMALE

Bladder irritation - Bed-Wetting .*

FORMICA RUFA

Joint Pain & Stiffness .*

URTICA URENS

Itching, Burning & Stinging skin conditions - Hives - Minor Burns – Allergic Reactions .*

UVA URSI

Bladder Irritation - Bloody, Painful and Burning Urination - Mucus-Laden Urine .*

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 13étiquette 13étuis 13étuis 13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-701276472-7012-1, 76472-7012-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
FORMICA RUFA55H0W83JO5ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
EQUISETUM HYEMALE59677RXH25ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Bladder Calm Urinary InfectionEQUISETUM HYEMALE 3C, FORMICA RUFA 5C, URTICA URENS 3C, UVA URSI 3CSEVENE USA5510749a-1aaa-152a-e063-6294a90aa2ff2026-08-18WarningsExact identifier
ndc (package): 76472-7012-2
ndc (package): 76472-7012-1
ndc (product): 76472-7012
ndc11 (package): 76472701201
ndc11 (package): 76472701202
spl id: 594f4a54-2572-401e-e063-6394a90aa6b4
spl set id: 5510749a-1aaa-152a-e063-6294a90aa2ff

Reported adverse events (FAERS/openFDA)#

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